Irrigation and aspiration devices and methods

ABSTRACT

Irrigation and/or aspiration devices and methods may be configured to aspirate and irrigate alone, sequentially, or concurrently. The devices and methods may provide a base with a removable head, and adapted for partial or complete separation of the irrigation and aspiration functions. The devices and methods can be configured to aspirate and/or irrigate the nasal and sinus cavities. The devices and methods may be manually and/or automatically controlled. The devices and methods may include removable, and/or replaceable, and/or refillable, and easily cleanable reservoirs for aspirant and irrigant. The device head and/or aspirant reservoir may comprise a diagnostic device, i.e., test device and/or container after use of the devices and methods.

RELATED APPLICATIONS

This application is a continuation-in-part of co-pending U.S. patentapplication Ser. No. 11/936,042, filed 6 Nov. 2007, and entitled“Irrigation and Aspiration Device and Method,” which claims priority toU.S. Provisional Application Ser. No. 60/857,457, filed 6 Nov. 2006, andU.S. Provisional Application Ser. No. 60/944,079, filed 14 Jun. 2007,all of which are incorporated by reference herein in their entireties.

FIELD OF THE INVENTION

The present invention relates generally to the field of medicine, andmore specifically to cavity, i.e., nasal aspiration and irrigation, asadministered in a medical setting, as well as in the home. Inparticular, the present devices and methods may be able to aspirate andirrigate simultaneously through one or more nozzles or catheters. Bothactions may be controlled separately or simultaneously by one or moreswitches.

BACKGROUND OF THE INVENTION

Nasal and sinus congestion is a ubiquitous problem in children andadults. Viral illnesses and environmental allergies in about 100 millionAmericans per year cause myriad symptoms including rhinitis (i.e., nasalinflammation), which causes congestion, rhinnorhea, and sinus blockage.This in turn can cause sinusitis, or more commonly, irritation, pain,and nasal cavity blockage, which causes poor sleeping and feeding ininfants and general discomfort and malaise in adults.

Diagnosis of the many potential conditions has been a tedious process atbest. Samples of mucus and/or nasal tissues must be taken and placed ina vial or specimen container. The sample is then typically sent to a labfor analysis, which may take hours, or longer, before results arereturned and a treatment regimen can be prescribed.

Current strategies for dealing with nasal and sinus congestion includeseveral types of orally and nasally administered over the countertherapies, such as decongestants and antihistamines, as well asprescription drugs such as steroids and antibiotics. While thesesolutions offer some relief, they entail serious drawbacks: they areexpensive, results are variable, and side-effects include reboundcongestion, hypertension, habit formation, and possible medicalinteractions. In pediatrics, there is no proven safe and effective overthe counter solution. Partial relief of congestion may also be met byblowing the nose, which may eventually be irritating to the adult anddifficult or impossible for a child or infant.

For these reasons, physicians have been turning increasingly to theage-old remedy of saline irrigation. Recently, several physiciansocieties have indicated saline irrigation as an adjunct therapy intheir practice guidelines, and nasal and sinus lavage is now commonlyprescribed, especially in pediatrics. Yet despite the increased interestin saline therapy, there is currently no adequate system for performingit.

It has been shown that nasal suctioning, alone or following salineirrigation, is an effective way of relieving symptoms and signs ofrhinitis. Nasal suctioning can circumvent the side effects of medicinesand irritation—or the impossibility—of nose blowing. Manual aspiratorshave long been used for nasal suctioning in infants. However, they donot provide enough airflow nor adequate evacuation time. As a result,they are variably efficacious and can be awkward and frustrating to use.Typical sinus irrigators designed for adults with sinusitis do notcircumvent the problem of painful evacuation or blowing.

Furthermore, nasal congestion from viral respiratory infections causesdifficulties with sleeping and eating in infants as they are obligatenose breathers. This leads to poor nutrition and restlessness which maydisrupt both the child's well being and the family's functioning. Worse,unresolved nasal congestion as part of an infant's viral syndrome canlead to emergency department visits or hospitalization for supplementaloxygen, frequent suctioning, and parenteral nutrition.

Several strategies are used to resolve nasal congestion. Several studieshave demonstrated futility of cold medications in relieving symptoms,and most parents learn that nasal irrigation and suctioning is the bestoption. Routine nasal irrigation improves symptoms in adults withchronic rhinosinusitis as well as children with allergic rhinitis.Additionally, several studies have shown that saline irrigation improvesnasal ciliary motility. It is thought that the saline draws fluid fromthe submucosal and adventitial space decreasing airway edema andsoftening the mucus, allowing easier suctioning. Additionally, thesaline is thought to stimulate channels in the cell membrane whichimproves the cell's function.

Such a combination of saline irrigation and suctioning has provenbenefits, especially for infants with bronchiolitis. Most studiesevaluating nasal suctioning used a hospital's central “wall” suction andsome studies even used deep nasopharyngeal suctioning, both of which arenot routinely available for clinic or home use. The studies demonstratedthat appropriate suctioning reduces the need for further interventions,such as nebulizations, oxygen supplementation, and hospital admissions.

In contrast to hospital wall suction, manual nasal aspirators areavailable for home use. Their maximal negative pressure and flow ratesare generally adequate, but their air flow is uncontrolled, hard to keepa seal on the nostril, and very brief, and they require repeatedmovements to and from the nose. Both parameters contribute to theirimperfect quality; more pressure has been shown to be optimal (80 to 100mmHg, for example) and the short duration of their action requiresrepeated attempts back and forth, rendering them awkward.

Typical bulb suction syringes offer some suction, but brief anduncontrolled pressures can limit their utility. Additionally, the narrowand long stem allow for the possibility of mucosal damage as well as aninadequate seal at the nares (nasal passages). Some manual aspiratorshave circumvented that problem by developing better nasal tips that haveimproved seal and safety.

Accordingly, there remains a need for improved devices and methods ableto aspirate and irrigate simultaneously through a nozzle, with thenozzle providing an improved seal. A need remains for improved devicesand methods able to provide a diagnostic function, and for both actionsof aspiration and irrigation to be controlled by the operator with asingle control (i.e., switch), so the devices and methods provide afaster and greater ease of use for both adults and children, includinginfants.

SUMMARY OF THE INVENTION

The invention provides improved devices and methods for providingirrigation and/or aspiration of a body including an opening, an orifice,a cavity, a lumen, a vessel, or a fold.

One aspect of the invention provides a hand-held test device. The devicecomprises a hand-held housing, the housing including a head and a base,the head and base being adapted to be releasably coupled to each otherat an interface region, an aspirant reservoir within the housing, theaspirant reservoir adapted to contain aspirated fluid, pumping meanswithin the housing adapted to draw fluid into the aspirant reservoir,and a diagnostic means within the housing for testing the aspiratedfluid, the diagnostic means adapted to provide an indication of theresults of testing the aspirated fluid.

In some embodiments, the device may further include a barrier meanswithin the housing adapted to retain liquid in the aspirant reservoirand allow gas to pass out of the aspirant reservoir.

In one embodiment, the diagnostic means may comprise at least one of atest strip, an electrical chip, a chemical, and a genetic plate. Thediagnostic means may be contained within the head and/or aspirantreservoir, and may be adapted to provide test results.

In some embodiments, the diagnostic means may include a sub-chamberwithin the aspirant reservoir, the sub-chamber adapted to deliver apredetermined volume of aspirated fluid to the diagnostic means. Thesub-chamber may include a port in fluid communication with the aspirantreservoir that allows negative pressure of the device to controlsub-chamber filling. A flexible portion may be included that is adaptedto be pressed to facilitate at least one of sub-chamber filling andevacuation of the aspirated fluid to the diagnostic means. A flexibleportion may also be included that is adapted to induce the addition of adiagnostic test reagent/primer into the sub-chamber to then be deliveredto the diagnostic means.

In some embodiments, the diagnostic means accommodates microbiologictests including influenza A and B, avian flu, RSV (respiratory syncytialvirus), adenovirus, Legionella, CNV, EBV, Group A beta hemolyticstreptococcus, S. pneumoniae, N. meningitides, mycoplasma, Staphloccusaureus, Malaria, HIV, rhinovirus, coccsackie virus, smallpox, anthrax,botulinum toxin, ricin, ebola, rabies, brucellosis, (plague) yersiniapestis, coxeilla burnetti (Q fever), T2 mycotoxins, francisellatularensis (tularemia), viral equine encephalitis, viral hemorrhagicfever, and burkholdria mallei (glanders).

In some embodiments, the diagnostic means accommodates toxicologicand/or chemical tests including amphetamines, cocaine, opiates,phencyclidine, tetrahydrocannabinol, acetaminophen, barbiturates,benzodiazepines, methadone, propoxyhenone, tricyclic antidepressants,calcium channel blockers, ethyl alcohol, ethylene glycol, ketones,glucose, hypoglaecemics, cytokines, interleukins, insulin, HemoglobinA1C, electrolytes, human choreonic gonadotropin (pregnancy test),thyroid-stimulating hormone (TSH), T3 blood test, T4 blood test,c-reactive protein (CRP), and erythrocyte sedimentation rate (ESR).

In some embodiments, the diagnostic means accommodates real timepolymerase chain reaction tests and/or immunoassays for viruses,bacteria, and cancers.

In some embodiments, the device further includes pumping means withinthe housing adapted to expel irrigation fluid from an irrigantreservoir, the irrigant reservoir adapted to contain irrigation fluid.

In some embodiments, the device may further include at least one nozzleextending from the housing, the nozzle including an irrigant lumen andan aspirant lumen, the irrigant lumen adapted to provide fluidcommunication between the irrigant reservoir and an irrigant port, theaspirant lumen adapted to provide fluid communication between theaspirant reservoir and an aspirant port.

In some embodiments, the interface region comprises at least onenon-fluid flow component and at least one gas flow component, theinterface region coupling the head to the base. The interface region mayalso comprise a seal between the head and the base, the seal adapted toallow a force exerted on the base to be transferred to the head, and theseal adapted to allow an aspiration pressure from the base to draw a gasout of the aspiration reservoir and into the base.

Another aspect of the invention provides a test device. The test devicecomprises a housing, an aspirant reservoir within the housing, theaspirant reservoir adapted to contain aspirated fluid, and a diagnosticmeans for testing the aspirated fluid, the diagnostic means adapted toprovide an indication of the results of testing the aspirated fluid.Coupling means may be included to couple the device to a source ofvacuum. Pumping means may be included for drawing fluid into theaspirant reservoir. The pumping means may draw the aspirated fluid intoor onto the diagnostic means.

In some embodiments, the diagnostic means may be adapted to provide testresults. The test results may comprise an indication on or in thehousing.

Yet another aspect of the invention provides a method of diagnosing anaspirated substance. The method comprises the steps of providing ahand-held test device, the test device comprising a hand-held housing,the housing including a head and a base, the head and base adapted to bereleasably coupled to each other at an interface region, an aspirantreservoir within the housing, the aspirant reservoir adapted to containaspirated fluid, the aspirant reservoir in fluid communication with anozzle in the head, pumping means within the housing adapted to drawfluid into the aspirant reservoir, control means adapted to operate thepumping means, and a diagnostic means within the housing for testing theaspirated fluid, the diagnostic means adapted to provide an indicationof the results of testing the aspirated fluid.

The steps may further comprise positioning the nozzle on or in anorifice, using the control means to activate the pumping means to drawfluid from the orifice, through the nozzle, and into the aspirantreservoir, using the hand-held test device to provide a sample of theaspirated fluid to the diagnostic means, testing the aspirated fluidwhile the fluid remains in the housing, and providing an indication ofthe results of the testing.

In some embodiments, the method may further include an irrigantreservoir within the housing, the irrigant reservoir adapted to containirrigation fluid, and using the control means to expel irrigation fluidfrom the irrigation reservoir, through the nozzle, and into the orifice.

In some embodiments, the interface region comprises at least onenon-fluid flow component and at least one gas flow component, theinterface region coupling the head to the base.

Yet an additional aspect of the invention provides a kit of devices toprovide an irrigation and aspiration system. The kit comprises a head,an aspirant reservoir within the head, the aspirant reservoir adapted tocontain aspirated fluid, at least one nozzle extending from the head,the nozzle including an aspirant lumen, the aspirant lumen adapted toprovide fluid communication between the aspirant reservoir and anaspirant port, and a diagnostic means within the head for testing theaspirated fluid.

The kit may also include a body, the body adapted to releasibly coupleto the head, the body including pumping means adapted to draw fluid intothe aspirant port and through the aspirant lumen and into the aspirantreservoir, and control means to operate the pumping means adapted todraw aspirated fluid.

The kit may also include instructions for use describing the operationand use of the irrigation and aspiration system, the instructionscomprising the operations of positioning the nozzle on or in an orifice,using the control means to activate the pumping means to draw fluid fromthe orifice, through the nozzle, and into the aspirant reservoir, usingthe hand-held test device to provide a sample of the aspirated fluid tothe diagnostic means, testing the aspirated fluid while the fluidremains in the housing, and providing an indication of the results ofthe testing.

One aspect of the invention provides a device for delivery and/orremoval of a fluid. The device comprises a housing, an irrigantreservoir within the housing, the irrigant reservoir adapted to containirrigation fluid, and an aspirant reservoir within the housing, theaspirant reservoir adapted to contain aspirated fluid. A barrier meansmay be adapted to retain aspirated liquid in the aspirant reservoir andallow gas to pass out of the aspirant reservoir. At least one nozzle mayextend from the housing, the nozzle including an irrigant lumen and anaspirant lumen, the irrigant lumen adapted to provide fluidcommunication between the irrigant reservoir and an irrigant port, theaspirant lumen adapted to provide fluid communication between theaspirant reservoir and an aspirant port. Pumping means may be adapted toexpel irrigation fluid from the irrigant reservoir through the irrigantlumen and out the irrigant port. An interface region may be included,the interface region comprising at least one non-fluid flow componentand at least one gas flow component.

Another aspect of the invention provides a hand-held device for deliveryand removal of fluids. The hand-held device comprises a removable andreplaceable head. The head comprises a housing, an irrigant reservoirwithin the housing, the irrigant reservoir adapted to contain irrigationfluid, an aspirant reservoir within the housing, the aspirant reservoiradapted to contain aspirated fluid, a barrier means adapted to retainaspirated liquid in the aspirant reservoir and allow gas to pass out ofthe aspirant reservoir, at least one nozzle extending from the housing,and a body, the body adapted to releasably couple to the housing, thebody including pumping means adapted to draw fluid into the aspirantreservoir, and pumping means adapted to expel irrigation fluid from theirrigant reservoir, and an interface region, the interface regioncomprising at least one non-fluid flow component and at least one gasflow component, the interface region coupling the head to the body.

One aspect of the invention provides a system for irrigation andaspiration of a body orifice. The system may comprise a head, the headadapted to contain a predetermined amount of irrigation fluid in anirrigation reservoir, and the head containing an aspiration reservoiradapted to contain a predetermined amount of aspirated fluid, a body,the body releasibly coupled to the head and containing pumping means todraw fluid into the aspiration reservoir, with the system defining avolume of about 200 cc to about 400 cc and sized and configured to beportable and operably held in a user's hand, and the system adapted toproduce an incoming fluid volume of about 5,000 cc/min to about 20,000cc/min.

In some embodiments, the system may be further adapted to produce anincoming fluid volume of about 5,000 cc/min to about 20,000 cc/min for aperiod of about one second to about 30 minutes.

In some embodiments, the system may be further adapted to produce anincoming fluid volume of about 5,000 cc/min to about 20,000 cc/min at apower consumption of about 5 watts to about 15 watts. A power source maycomprise a capacity of about 100 mAh to about 1000 mAh.

One aspect of the invention provides a system for irrigation and/oraspiration of an orifice. The system comprises an irrigation function,an aspiration function, and user controls.

The irrigation function comprises an irrigation force and an irrigationreservoir, the irrigation reservoir adapted to contain an irrigationfluid, the irrigation force initiated by user input to the irrigationfunction, the irrigation force acting upon the irrigation reservoir toexpel irrigation fluid from the irrigation reservoir and into theorifice.

The aspiration function comprises an aspiration pressure and anaspiration reservoir, the aspiration reservoir adapted to captureaspirated fluid, the aspiration reservoir adapted to retain aspiratedliquid in the aspiration reservoir and allow gas to pass out of theaspiration reservoir.

The user controls may be adapted to provide a control function for atleast one of the irrigation function and the aspiration function, theirrigation function being operational intermittently or simultaneouslywith the operation of the aspiration function.

The irrigation function may be operational with no interaction with theaspiration function, and the aspiration function being operational withno interaction with the irrigation function.

Other features and advantages of the inventions are set forth in thefollowing specification and attached drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an anatomical lateral view in section of a head, and showingthe nasal and sinus cavities.

FIG. 2 is an anatomical anterior view of the face, and showing the fourparanasal sinuses that communicate with the nasal cavity.

FIG. 3 is a perspective view of a variation of a device adapted forirrigation and aspiration.

FIG. 4 is a side view of a variation of the irrigation and aspirationdevice shown in FIG. 3.

FIG. 5A is an anatomical lateral view in section of a head as shown inFIG. 1, and showing a variation of an irrigation and aspiration deviceas shown in FIG. 3 providing both irrigation and aspiration functions,and the ability of the device to articulate or flex while maintaining aseal with the nostril.

FIG. 5B is a close-up anatomical inferior view of a variation of theflexible tip of the device providing the seal with the nostril, andirrigation and aspiration channels extending through the flexible tipand into the nasal cavity, providing the ability to irrigate andaspirate simultaneously.

FIG. 6 is an exploded view of a variation of a device as shown in FIG. 3adapted for irrigation and aspiration.

FIG. 7A is a plan view of a variation of a kit packaging the irrigationand aspiration device as shown in FIG. 3, along with instructions foruse.

FIG. 7B is a plan view of an alternative kit similar to that shown inFIG. 7A, the alternative kit packaging extra irrigant, along withinstructions for use.

FIG. 8A is a perspective view of a variation of a seal that may beincluded between the head and the body of the irrigation and aspirationdevice.

FIG. 8B is a perspective view of a variation of the irrigation andaspiration device, with the head removed from the body of the device,and showing the seal of FIG. 8A positioned on the body, and showingfeatures of the invention that comprise at least a portion of aninterface region.

FIG. 8C is a perspective view similar to FIG. 8B, except with the sealand body shown in an exploded configuration, showing features of theinvention that interact with the seal and comprise at least a portion ofan interface region.

FIG. 9 is a side view of a variation of the irrigation and aspirationdevice in a user's hand.

FIG. 10A is a side view of a variation of the irrigation and aspirationdevice showing the head removed from the body of the device, and showingfeatures of the invention that comprise at least a portion of aninterface region.

FIG. 10B is a rear view of the head and a front view of the base,showing features of the seal and the head that comprise at least aportion of an interface region.

FIG. 11A is an exploded view of a variation of the head of theirrigation and aspiration device, and showing the head comprising bothan irrigation reservoir and an aspiration reservoir.

FIG. 11B is a close-up view of a proximal portion of the flexible tip,and showing an irrigation channel and an aspiration channel.

FIG. 12 is an additional exploded view of a variation of the head of theirrigation and aspiration device, as shown in FIG. 11A.

FIGS. 13A and 13B are rear and side views of variations of a head of theirrigation and aspiration device, and showing the head including barriermeans including vanes and/or baffles.

FIG. 14 is a side view of a variation of a head of the irrigation andaspiration device, and showing the head including a flexible region toallow the head to be squeezed to expel irrigation fluid.

FIG. 15A is a perspective view of a variation of a head of theirrigation and aspiration device, and showing the head comprisingremovable or replaceable, or reusable or disposable irrigation and/oraspiration reservoirs.

FIG. 15B is a side view in partial phantom showing an alternativevariation of a head of the irrigation and aspiration device, and showinga flexible tip integral with the head and/or shell of the head.

FIG. 15C is a perspective view of an alternative variation of a head ofthe irrigation and aspiration device, and showing the head comprising analternative shape and configuration and being removable or replaceable,or reusable or disposable with irrigation and/or aspiration reservoirs.

FIG. 15D is a perspective view of an alternative variation of a head ofthe irrigation and aspiration device, and showing the head comprising analternative shape and configuration, including a combined head andflexible tip configuration, and being removable or replaceable, orreusable or disposable with irrigation and/or aspiration reservoirs.

FIG. 16 is a side view of a variation of the flexible tip, with the capremoved.

FIG. 17 is a front view of a variation of the flexible tip, as shown inFIG. 16.

FIG. 18 is a perspective view of a variation of the flexible tip,showing the flexible tip with recessed and eccentric irrigation andaspiration ports.

FIG. 19 is a side view in section of a variation of the head of theirrigation and aspiration device, and showing the head including both anirrigation reservoir and an aspiration reservoir, and irrigation andaspiration flow channels, the configuration adapted to provide completeisolation of irrigation and aspiration fluids while allowingsimultaneous irrigation and aspiration out of a single tip or nozzle.

FIG. 20 is a side view in section of a variation of the head of theirrigation and aspiration device as shown in FIG. 19, and showing theflexible tip including multiple irrigation and aspiration ports.

FIG. 21 is a side view of a variation of the head of the irrigation andaspiration device, showing various methods for filling the irrigationand aspiration device with irrigant.

FIGS. 22A through 22C are schematic views in partial cutaway showingvariations of the head of the irrigation and aspiration device includingalternative configurations for diagnostic means.

FIG. 23 is a perspective view with partial cutaway of a variation of theirrigation and aspiration device, showing a power source carried in thebase of the device.

FIG. 24 is a perspective view of a variation of a power source rechargeradapted to recharge the irrigation and aspiration device when the deviceincorporates a rechargeable power source.

FIG. 25 is a perspective view of a variation of the head of theirrigation and aspiration device, showing a variation of the controlsadapted to provide user control of either or both the irrigationfunction and the aspiration function.

FIGS. 26 through 29 illustrate a variation of a method of using avariation of the irrigation and aspiration device.

FIG. 30 is an exploded view of a variation of a pump and motor adaptedfor use with a variation of the irrigation and aspiration device.

FIG. 31 is a section view of the pump as shown in FIG. 30.

FIG. 32 is an exploded view of an alternative variation of the pump andmotor as shown in FIG. 30.

FIG. 33 is a perspective view of a variation of the head of theirrigation and aspiration device, similar to the head shown in FIG. 25,showing a variation of the controls adapted to provide user control ofthe irrigation function.

FIG. 34A is a side exploded view in partial cutaway of the head of theirrigation and aspiration device shown in FIG. 33, showing a variationof the controls adapted to provide either direct or indirect usercontrol of the irrigation function, and showing features of theinvention that comprise at least a portion of an interface region.

FIG. 34B is a perspective view of the head of the irrigation andaspiration device shown in FIG. 34A, showing a variation of the controlsadapted to provide a transfer of force from the user control of theirrigation function.

FIGS. 35A and 35B are schematic diagrams of variations of the irrigationand aspiration device in various configurations.

FIG. 36 is a partially see-through view of a variation of the irrigationand aspiration device.

FIG. 37 is a cut-away view of a variation of the aspiration component ofthe irrigation and aspiration device.

FIG. 38 is a cut-away view of a variation of the irrigation andaspiration device.

FIG. 39 is a partial cut-away view and partial schematic diagrams of avariation of the irrigation and aspiration device.

FIG. 40 is partial cut-away view and partial schematic diagrams of avariation of the irrigation and aspiration device.

FIG. 41 is partial cut-away view, partial see-through view and partialschematic diagram of a variation of the irrigation and aspirationdevice.

FIG. 42 illustrates a variation of a method of using a variation of theirrigation and aspiration device.

FIG. 43 is a schematic diagram of a variation of the irrigation andaspiration device with a remote component.

FIG. 44 is a perspective view of a variation of an irrigation andaspiration device, showing the device including dual nozzles.

FIG. 45 is a generally superior anatomical view in section of apatient's nasal and sinus cavities, and showing the use of a variationof an irrigation and aspiration device comprising dual tips, andirrigating from one tip, through the nasal and sinus cavities, andaspirating from the other tip.

FIG. 46 is a side view of a variation of an irrigation and aspirationdevice, showing the device including a trigger or handle for pressuregeneration and controlled release.

FIG. 47 is a side view of a variation of an irrigation and aspirationdevice, showing the device including a canister for storage ofcompressed gas for pressure generation and controlled release.

FIGS. 48A through 49B are side views of a variation of an irrigation andaspiration device, showing the device including a bellows for pressuregeneration and controlled release.

DESCRIPTION OF THE PREFERRED EMBODIMENT

Although the disclosure hereof is detailed and exact to enable thoseskilled in the art to practice the invention, the physical embodimentsherein disclosed merely exemplify the invention which may be embodied inother specific structures. While the preferred embodiments have beendescribed in relation to use at the nostrils to provide relief withinthe nasal and sinus cavities, the details may be changed withoutdeparting from the invention, which is defined by the claims. Still, itshould be appreciated that the devices and methods that embody featuresof the invention are also adaptable for use at any site or cavity whereeither or both irrigation and aspiration may be beneficial.

When referring to an irrigation and aspiration device that ismanipulated by a physician or operator in order to irrigate and/oraspirate a site or cavity, the terms “proximal” and “distal” may be usedto describe the relation or orientation of the device with respect tothe operator as it is used. Therefore, the term “proximal” will be usedto describe a relation or orientation of the device that, when in use,is positioned toward the operator (i.e., at the handle or base end ofthe device), and the term “distal” will be used to describe a positionor orientation of the device that, when in use, is positioned away fromthe operator (i.e., at the other end of the device, such as the head andnozzle or catheter).

The terms aspiration and aspirant are used interchangeably herein whenused as descriptors for elements (e.g., aspiration reservoir 40 andaspirant reservoir 40), and/or functionality. The terms irrigation andirrigant are used interchangeably herein when used as descriptors forelements, and/or functionality. The terms atomizing and atomization areused interchangeably herein when used as descriptors for elements and/orfunctionality.

Any elements described herein as singular can be pluralized (i.e.,anything described as “one” can be more than one). Any species elementof a genus element can have the characteristics or elements of any otherspecies element of that genus. The described configurations, elements orcomplete assemblies and methods and their elements for carrying out theinvention, and variations of aspects of the invention can be combinedand modified with each other in any combination.

I. Nasal Cavity Anatomy

The devices and methods are particularly well suited for treating nasaland sinus congestion and associated symptoms due to a wide variety ofpossible causes. For this reason, the devices and methods will bedescribed in this context. Still, it should be appreciated that thedisclosed devices and methods are applicable for use in treating othersymptoms elsewhere in the body, which are not necessarily nasal related.

The nose functions in the respiratory system as the opening for thepassage of air. As can be seen in FIGS. 1 and 2, bone support occurs inthe upper half of the nose, whereas most of the lower half, includingthe wings of the nostrils, is cartilage. The partly bony andcartilaginous nasal septum divides the chambers of the nose into twonasal cavities. There are four paranasal sinuses that communicate withthe nasal cavity: the maxillary, ethmoidal, frontal, and sphenoidal.

The area inside the nostril where nasal hair grows is called thevestibule. Farther inside the nasal cavity are the conchae. The nasalconchae are shelf-like protrusions on the walls of the nasal cavity. Themucous glands are found on the lowest of these—the inferior nasalconcha. On the surface of the conchae are cilia that continuouslyundulate to move mucus toward the external naris. The uppermost part ofthe nasal cavity is the region where the olfactory organs are located.

The functions of the nasal cavity include cleaning, heating, andmoistening the air that is breathed in. Inhaled air passes mainlythrough the middle nasal meatus (above the inferior nasal concha), where60 to 70 percent of the dust is removed and the air is converted to atemperature of 25 to 35 degrees Celsius and a humidity of 35 to 80percent.

Mucous membranes line the nasal cavity. The olfactory receptor cells arelocated in the superior nasal conchae, and many olfactory cilia arelocated in the surface mucous membrane. The minute particles that arethe source of a smell dissolve in the mucus and stimulate the cilia,which transform them into electrical signals. The signals travel throughthe olfactory bulb, and reach the olfactory center of the cerebralneocortex, resulting in sensory perception of smell.

Because the paranasal sinuses are continuous with the nasal cavitiesthrough apertures that open into them, infection may spread from thenasal cavities, producing inflammation and swelling of the mucosa of thesinuses (sinusitis) and local pain. Sometimes several sinuses areinflamed (pansinusitis), and the swelling of the mucosa may block one ormore openings of the sinuses into the naval cavities.

The presence of some mucus in the nose and throat is normal, butincreased quantities can impede comfortable breathing and may be clearedby attempts at blowing the nose or expectorating phlegm from the throat.

In the case of bacterial infection, the bacterium becomes trapped inalready clogged sinuses, breeding in the moist, nutrient-richenvironment. Antibiotics may be used fruitfully to treat the secondaryinfection in these cases, but will generally not help with the originalcause.

II. Irrigation and/or Aspiration Device Overview

FIGS. 3 and 4 illustrate a cleaning device 2 or system for irrigationand/or aspiration of biological tissues or fluids. The device 2 can beused in or on a body orifice, including a cavity or lumen or vessel orfold, such as the vestibule of the nose, nasal cavity, the mouth and/orthroat, the ear, the eye, a skin fold, the bellybutton, a wound, orcombinations thereof. The device 2 can be inserted into a natural bodyorifice, including a cavity or lumen or vessel or fold, such as anostril, the mouth—including access to the throat, esophagus, stomach,and lungs, ear canal, eye, naval, rectum, urethra, vagina, or adipose orfat fold, a wound, a surgical device (e.g., surgery port), orcombinations thereof, all as non-limiting examples.

For example, the device 2 can be configured to perform nasal aspirationand/or nasal irrigation alone, interlaced, sequentially, orsimultaneously, for example (see FIG. 5). Aspiration can includesuctioning, i.e., the production of a vacuum or negative pressure via apump and/or venturi effect, for example. The device 2 can be configuredto irrigate and aspirate one at a time and/or concurrently. The device 2can have an automatically driven vacuum and a manually actuatedirrigation, both of which can operate simultaneously. The device 2 canhave an automatically driven vacuum and an automatically actuatedirrigation, both of which can operate simultaneously. The device 2 canhave a manually driven vacuum and a manually actuated irrigation, bothof which can operate simultaneously. The device 2 can have a manuallydriven vacuum and an automatically actuated irrigation, both of whichcan operate simultaneously. The device 2 may also be configured toseparate the irrigation and aspiration functions, including separationof irrigation and aspiration fluids. Irrigation actuation may becontrolled separately from aspiration actuation. Irrigant flow may becompletely or partially separate from aspirant flow.

The device 2 comprises a variety of desirable technical features. As canbe seen in FIG. 6, the device 2 may include a body 4 removably coupledto a head 14. Both the body 4 and head 14 may be single use, reusable,replaceable, and/or disposable. The body 4 and head 14 may be providedto the user as clean, but not sterile, or sterile. The body 4 comprisesa case 5, and within and/or on the case is shown a power supply 6, apump 8, a motor 9, and user controls 10. The pump 8 and/or motor 9 maybe optimized to provide high sustained flow rates with low maximumvacuum pressures. The head 14 is shown including a shell 16, a flexibletip 18, a cap 20, diagnostic means 22, barrier means 24, an irrigantreservoir 30, and an aspirant reservoir 40. Combining the irrigantreservoir 30 and the aspirant reservoir 40 into a disposable and/orreusable head 14 helps to provide isolation of potentially contaminatedfluids. The irrigation fluid 32 may be contained in the head 14 and maynever enter the body 4, or may be contained in both the body 4 and head14, or just in the body 4. The barrier 24 may prevent contaminatedaspiration material 42 i.e., fluids, from entering the body 4. Each ofthe desirable technical features will be described in greater detailbelow.

The device 2 can be configured at full power to aspirate, for example,up to about 20,000 cc/min. (1,220 in³/min.), or more narrowly 15,000cc/min (915 in³/min), or more narrowly 10,000 cc/min (610 in³/min), ormore narrowly 5,000 cc/min (305 in³/min), or more or less, of air withno or minimal flow restriction for a time period of up to one second, orone minute, or one half hour, or one hour, or two hours, or more or lessof continuous use, for example.

The device 2 can be configured at full power to produce aspirationsuction with no or minimal flow restriction, for example, up to about200 mm Hg (3.86 psi), or more narrowly about 120 mm Hg (2.32 psi), ormore narrowly about 80 mm Hg (1.55 psi), or more narrowly about 50 mmHg(0.966 psi), or more or less, for a time period of up to one half hour,or one hour, or two hours, or more or less, of continuous use, forexample. The device 2 may include a vacuum limiting valve 128 as asafety feature to limit the available vacuum to 100 mm Hg, for example.

The device 2 can be configured at full power for automatic irrigation toirrigate up to about 3 cc/min. (0.183 in³/min.), or more narrowly about1.5 cc/min. (0.092 in³/min.), or more narrowly about 0.5 cc/min. (0.031in³/min.), or more or less, of irrigant 32 with no or minimal flowrestriction.

The device 2 can be configured for manual irrigation to irrigate up toabout 1.0 cc, or more narrowly 0.5 cc, or more narrowly 0.25 cc, or moreor less, per depression, or activation, either direct or indirect, forexample, e.g., per stroke of a piston or plunger or syringe or pump 11.

The device 2 can be configured at full power to use about 15 watts, ormore narrowly about 10 watts, or more narrowly about 5 watts, or more orless. The amount of watts used generally depends on the amount of vacuumdraw, i.e., the amount of restriction to the flow of air duringaspiration.

The device 2 can be configured at full power to generate a noise levelof about 40 db, or more narrowly about 30 db, or more narrowly about 20db, or more or less. The amount of noise level generated generallydepends on the amount of vacuum draw, i.e., the amount of restriction tothe flow of air during aspiration.

The device 2 can be configured to be portable. For example, the device 2can be unattached to any external devices (e.g., a wall or floor-mountedoutlet or source for power, pressure, irrigant, or an aspirantreservoir). The device 2 can be configured to be connected to wallvacuum or a portable vacuum pump, for example.

The device 2 can be configured to be ergonomic and handheld. Forexample, the device 2 can weigh about 5.0 kg (11 lbs.), more narrowlyabout 2.0 kg (4.4 lbs.), more narrowly about 1.0 kg (2.2 lbs.), forexample about 0.45 kg (1.0 lbs.), or more or less.

The device 2 can have a total maximum height, for example, of less thanabout 40 cm (16 in.), more narrowly less than about 30 cm (12 in.), yetmore narrowly less than about 25 cm (10 in.), and may include a heightabout 21.5 cm (8.5 in.), or more or less. The device 2 can have a totalmaximum width, for example, of less than about 41 cm (16 in.), morenarrowly less than about 30 cm (12 in.), yet more narrowly less thanabout 25 cm (10 in.), and may include a width about 5 cm (2 in.), ormore or less. The device 2 can have a total maximum diameter, forexample, of less than about 20 cm (8 in.), more narrowly less than about15 cm (6 in.), yet more narrowly less than about 10 cm (4 in.), and mayinclude a width about 9 cm (3.5 in.), or more or less.

The device 2 can have a total volume. For example, the device 2 can havea volume of about 400 cc (24.5 in³), more narrowly about 300 cc (18.3in³), and more narrowly about 200 cc (12.2 in³), or more or less.

The device 2 can be used to deliver fluids, for example, water, saline,therapeutic drugs, herbal medicines, vaccines, diagnostic agents,antiseptic agents, powders, and in any combination. The device 2 can beused to deliver fluids to any of the body cavity or body orifice regionsdescribed above.

III. System Kits

As FIG. 7A shows, the cleaning device 2 as just described can beconsolidated for use in a multiple piece functional kit or kits 50. Itis to be appreciated that the various components are not necessarilyshown to scale.

The kit 50 can take various forms. In the illustrated embodiment, thekit 50 comprises an assemblage of individual packages 51, 52, 53, and54. Each or one or more of the packages may comprise a clean or sterile,packaged or bagged assembly. One or more of the packages may include aninterior tray or card made, e.g., from die cut cardboard, plastic sheet,or thermo-formed plastic material, for example, which hold the contents.The kit 50 also preferably includes instructions or directions 58 forusing the contents of the packages to carry out a desired procedure. Aprocedure using the contents of the kit 50 shown in FIG. 7A will bedescribed in greater detail later.

The instructions for use 58 can, of course vary. The instructions foruse 58 can be physically present in one or more of the packages, but canalso be supplied separately. The instructions for use 58 can be embodiedin separate instruction manuals, or in video or audio recordings. Theinstructions for use 58 can also be available through an internet webpage.

A. The Component Packages

The arrangement and contents of the packages can vary. For example, asshown in FIG. 7A, the kit 50 comprises the packages 51, 52, 53, and 54,and instructions 58. Two of these packages 51 and 52 provide the maincomponents of the cleaning device 2 as described, with the body 4 inpackage 51 and the head 14 in package 52. The remaining packages 53 and54 may or may not be included and provide ancillary component(s) used inconnection with the device 2, e.g., a container 56 of irrigation fluidin package 53, and a recharger base 62 in package 54, and. In package52, the head 14 of the device 2 may be preloaded with irrigation fluid32.

The kit 60 (see FIG. 7B) may be included as a component of kit 50, ormay be a stand-alone kit. The kit 60 may comprise a predeterminedquantity of irrigant containers 56, for example the kit 60 is shownincluding 10 irrigant containers 56, although more or less may beincluded. Instructions for use 58 may also be provided to instruct theuser on how to use the device 2 and/or the irrigant containers 56 torefill the irrigant reservoir 30 with irrigant 32. A supply of flexibletips 18 may also be provided in a kit.

It is to be appreciated that additional arrangements of kits are alsopossible. For example, a kit or kits may contain additional componentsdirected to diagnostic devices adapted to test the fluids aspirated. Inaddition, a kit or kits may contain variations of the device 2,including non-rechargeable devices, non-battery powered devices, and/ormanual devices, as non-limiting examples.

IV. Desirable Technical Features for Irrigation and Aspiration

The cleaning device 2 can incorporate various technical features toenhance its universality, including irrigation and aspiration functions.

A. Hand-Held Form

1. Body

According to one desirable technical feature, the device 2 can comprisea reusable and/or disposable ergonomic body 4 (e.g., handle), releasablycoupled to a head 14, the device 2 adapted for use and ease of controlby a user in one hand, either left or right.

As seen in FIG. 6, the body 4 can encase a rechargeable ornon-rechargeable power source 6, such as a battery and/or a source ofcompressed gas. The body 4 may also be connected to an external powersource, e.g., via a power cord (not shown). The body 4 can be configuredto be connected to a source of vacuum, e.g., wall vacuum or a portablevacuum pump. The body 4 can have a fluid control system for irrigationand/or aspiration. The fluid control system can have one or more pumps 8and 11. The fluid control system can have a driving motor 9. Eithermeans for pumping 8 and/or 11 can be manually operated (e.g., squeeze,push, and/or trigger operated), or automatically operated (e.g., AC orDC electrically powered, compressed gas, stored energy, venturi port).Either pump 8 and/or 11 can be or have a syringe, a flexible orsqueezable component, a piston pump, a blower, a turbine, a fan, alinear pump, a rotary vane pump, a centrifugal pump, a reciprocatingpump, a diaphragm pump or combinations thereof, as non-limitingexamples. The motor 9 can be part of a pump or a separate component.

The outer case 5 as well as internal portions of the body 4 can be madefrom a plastic, for example ABS, polycarbonate, or a combinationthereof. The outer case 5 as well as internal portions of the body 4 canbe made by injection molding, for example by injection molding halvesand assembling. As can be seen in FIG. 6, the outer case 5 is showncomprising two halves, although it is to be appreciated that more orless pieces may be used.

The body 4 (and/or head 14) can have an attachment ring or seal 66 onthe inside or outside of the body 4 (and/or head 14). The seal 66 can beconfigured to provide a fluid tight coupling between the body 4 and thehead 14, as a component of the interface region 13. As seen in FIGS. 8Athrough 8C, the seal 66 may include a bellows 68 and a passage 70. Thebellows 68 provides a fluid tight seal between the pump 11 in the baseand the irrigant reservoir 30 in the head 14. The passage 70 allows theflow of fluid, i.e., air, from the aspirant reservoir 40, through thebarrier 24, and to the pump 8 in the base 4. The seal 66 may be adaptedto provide separation of the irrigation and aspiration systems andfunctions. The seal 66 may be adapted to allow an irrigation forceexerted on the base 4 to be transferred to the head, and the seal may beadapted to allow an aspiration pressure from the base 4 to draw gas outof the aspiration reservoir 40 and into the base 4.

As seen in FIG. 8C, a component 188 of the pump 11 may be configured toapply a direct or indirect force to the bellows 68. This force may thenbe translated to the head 14 to eject irrigant from the irrigantreservoir 30.

As can be seen in FIG. 9, the body 4 can be configured to beergonomically held in one hand. The body 4 can have contours to fit thepalm 74 and fingers 76 when grasped. The body 4 may include grip pads78. The grip pads 78 may comprise soft rubber, metal, soft plastic, orother known materials, and may be attached and/or integral with the body4. The grip pads 78 may be smooth, and they may have ridges ortexturing, or combinations thereof. The grip pads 78 can beergonomically located about the body 4, and the pads 78 can beconfigured to be located at all or some of the locations where the user(e.g., the user's palm) naturally applies pressure to the body 4 duringuse.

The body 4 (and/or head 14) can have various colors, and may betransparent, translucent, and/or opaque materials. The body 4 (and/orhead 14) may also incorporate forms of indication such as lights, forexample, for operational purposes and/or for entertainment of the userand/or patient. The body 4 (and/or head 14) may incorporate a “key” orfitment element 15 for required registration of the head 14 to the body4. Connectors 12 (described below) may provide this feature. The body 4may communicate with the head 14, and the head 14 may communicate withthe body 4, e.g., electrical communication between the body 4 and thehead 14, for diagnostic, status, or indication purposes, for example.

Any oscillations or vibrations of the device 2 (e.g., due to movingparts such as pumps, motors, reciprocating solenoids, piezoelectrictransducers) can be dampened. Moving parts can be mounted to the body 4or head 14 using dampers, such as soft rubber washers. Excessivepressure and pump exhausts can be muffled, for example using arestricting plate in an exhaust conduit 166. The walls of the device 2(e.g., case 5 and shell 16) can be thickened and made from layeredand/or laminated materials. The walls of the device 2 can be otherwisesound-proofed. Moving parts in the device 2 can be dynamically balanced,for example such that all support forces sum to zero at any giveninstant and/or the device 2 can have active noise cancellation. Motors(e.g., in or coupled to a pump) can have counterbalances. Multiplemotors can be configured to oppose dynamic forces.

With a filled irrigant reservoir 30 and/or aspirant reservoir 40 andin-body power source 6 (as described below), the device 2 can weighabout 5.0 kg (11 lbs.), more narrowly about 2.0 kg (4.4 lbs.), morenarrowly about 1.0 kg (2.2 lbs.), for example about 0.45 kg (1.0 lbs.),or more or less. The irrigant 30 and/or aspirant reservoirs 40 can betranslucent and/or transparent, for example to allow a user to identifywhen to replace/refill irrigant 32 and/or empty aspirant 42, and/or tocheck cleanliness and/or operation of the device 2.

2. Head

According to one desirable technical feature, the head 14 can beremovably attached (see FIGS. 10A and 10B) or integral with the body 4.The head 14 can be positioned at varying angles relative to the body 4,and may be adapted to articulate and/or flex and/or pivot freelyrelative to the body 4. The connections of the head 14 to the body 4 canbe compliant and flexible so as the head 14 can pivot and translate fromthe perimeter of the head 14 (this is stated for exemplary purposesonly, there are multiple mechanical solutions). The head 14 can beremovably attached to the body 4 with a (one or more) connector(s) 12.The head 14 may be pressed onto the body 4 until the connectors 12 clickthe head 14 into place. The connector 12 can be a screw, snap, press fitconnector, or combinations thereof, as non-limiting examples.

The irrigation and/or aspiration systems, methods, and functions mayhave or include an interface region 13 between and/or including portionsof the body 4 and the head 14. The interface region may directly orindirectly connect a pump to a reservoir and/or a vacuum pressure to areservoir, for example. The interface region 13 may be adapted toprovide separation of the irrigation and aspiration systems, methods,and functions.

The interface region 13 can, for example, include a non-fluid flowregion or component(s), such as the irrigant plug 28 and/or the bellows68 and/or the irrigation aperture 190, where a force 180 may betransferred, and the interface region 13 can, for example, include a gasflow region or component(s), such as the passage 70 and/or theaspiration aperture 192, where a gas may be transferred. The interfaceregion 13 can, for example, enable the head 14 to be removed from thebody 4, to allow the irrigant reservoir 30 and aspirant reservoir 40 tobe contained within the head 14, so as to eliminate potentialcontamination of the body 4 with any contaminated fluids. Part(s) of theirrigation and/or aspiration functions may be removed with the head 14,and remaining portions of the irrigation and/or aspiration functions mayremain attached to or integral with the body 4, as will be describedlater. The interface region 13 may also enable rotation and translationbetween the head 14 and the body 4.

As can be seen in FIGS. 11A through 12, the head 14 may comprise a shell16 and a back 26. A flexible nozzle or catheter or tip 18 may protrudedistally from the shell 16, and may include a cap 20 to be positioned onor in or over the flexible tip 18 when the device 2 is not in use,and/or for diagnostic purposes. The cap 20 may include a breakable sealout of the package, and with the first use, the seal is broken. The cap20 may then be repositioned on or in the flexible tip 18. The irrigantreservoir 30 and the aspiration reservoir 40 are shown within the shell16, and may both be in fluid communication with the flexible tip 18.

In some embodiments, barrier means 24 may be positioned in the head 14and/or the body 4. In some embodiments, barrier means 24 may bepositioned adjacent or within a recess 27 in the back 26. For example,the barrier 24 may comprise a filter, such as a hydrophobic filter, afoam, a sponge, or other materials, such as cotton in the form of a ballor other desirable shapes, or any combination.

The barrier means 24 may have a shape adapted for optimal use within thehead 14 and back 26. A shape, such as a kidney shape, provides efficientuse of surface area within the head 14, and thus decreases the amount ofresistance the barrier means provides, although other linear andnon-linear shapes are possible, such as round, square, triangle,deformable, baffled, or random, for example. In some embodiments, thebarrier means 24 may comprise a 10 micron filter, more narrowly an 8micron filter, and more narrowly about a 5 micron filter, or more orless. The barrier means 24 may be configured to allow a gas (i.e., air)to pass out of the aspirant reservoir 40, while not allowing a liquid(i.e., aspirant fluids 42) to pass out of the aspirant reservoir. Thebarrier means maintains a separation of aspiration fluids 42 between thedisposable head 14 and the body 4.

In some embodiments, the barrier means 24 may include or comprise vanesand/or baffles and/or corridors within the head 14 or body 4 to increaseresistance of aspirated fluid 42 from entering the body 14 (see FIGS.13A and 13B). The vanes and/or baffles and/or corridors may also be incombination with any of the materials as previously described.

An irrigant plug 28 may be positioned adjacent or within the back 26and/or irrigant reservoir 30. As previously described, the head 14(and/or body 4) can include a seal 66 to provide a fluid tight couplingbetween the body 4 and the head 14. The bellows 68 within the seal 66interacts with the plug 28 to allow the pump 11 in the base 4 to providea pressure 180 to the irrigant reservoir 30 to expel or eject theirrigant fluid 32.

Just as with the body 4, components of the head 14 described above canbe opaque, transparent and/or translucent, and may also have variouscolors.

In some embodiments, irrigant 32 may be ejected in various ways. Forexample, in some embodiments, irrigant 32 may be ejected using arack-and-pinion configuration, providing a mechanical advantage. Inother embodiments, irrigant 32 may be ejected using a direct linkage.And in other embodiments, portions of the head 14 may include one ormore deformable or flexible sections 72 to allow the user to squeeze theirrigation reservoir 30 to expel irrigant 32 (see FIG. 14). The user mayuse a finger or thumb 77, as shown, to apply a pressure to the flexiblesection 72 to produce a desired irrigation pressure.

In some embodiments, when the irrigant reservoir 30 is empty and/or theaspirant reservoir 40 is full or otherwise in need of emptying orcleaning, the entire head 14 can be removed from the body 4 and replacedwith a new head 14 containing more irrigant 32 in the irrigant reservoir30.

FIGS. 15A through 15D illustrate alternative embodiments of the head 14.FIG. 15A shows an embodiment where the head 14 includes an irrigationreservoir cartridge 30 and/or an aspiration cartridge 40 configured toremovably attach to the head 14. The head 14 and/or irrigation reservoircartridge 30 and/or aspiration cartridge 40 can have ports, hooks,latches, pegs, or combinations thereof that can removably attach to thesame on the head or cartridges. When the irrigant cartridge 30 is notattached, the cartridge receptacle can define a void substantiallyequivalent to the configuration of the irrigant cartridge 30.

The irrigant reservoir cartridge 30 can have one or more ports (notshown) that can engage the head 14. The ports on the irrigant reservoircartridge 30 can be closed or covered, for example by adhered aluminumfoil when the irrigant cartridge 30 is not in the head 14. For example,the head 14 can have one or more fangs or tubes configured to pierce theirrigant reservoir cartridge 30 (e.g., through a foil or seal) and be influid communication with the interior of the irrigant reservoircartridge 30 and pressurize or depressurize the irrigant reservoircartridge 30 and/or withdraw irrigant from the irrigant reservoircartridge 30.

A first irrigant reservoir cartridge 30 can be removed from the head 14and replaced with a second irrigant reservoir cartridge 30, for examplewhen the first irrigant reservoir cartridge 30 is empty.

FIG. 15B shows an embodiment of the head 14 where the flexible tip 18may be integral with the head 14 and/or the shell 16 of the head. Aflexible region 17 as part of the shell may couple to the tip 18,allowing the tip 18 to flex.

FIG. 15C shows an embodiment of the head 14 where the head includes anirrigation reservoir 30 and an aspiration reservoir 40 side by side. Thehead comprises a form factor more similar to a cartridge configuration.

FIG. 15D shows an embodiment of the head 14 where the head includes anirrigation reservoir 30 positioned within an aspiration reservoir 40.The head 14 comprises a form factor including a unitary head 14 andflexible tip 18.

The irrigant reservoir 30 and/or the aspirant reservoir 40 can beremoved for cleaning or replacement, such as in the form of thecartridge, for example, as described above. The aspirant reservoir 40may be removed, and may also be sealed, for diagnostic purposes, as willbe described in greater detail later. Access to the aspirant reservoiror cartridge 40 may be provided to allow access to the aspirant fluid 42for testing.

The head 14 and/or irrigant reservoir 30 and/or aspirant reservoir 40and/or the device 2 can be washed, for example, by hand and/or in adishwasher. The body 4 and/or the device 2 can be waterproof.

The head 14 and/or irrigant 30 and/or aspirant reservoirs 40 can becleanable, for example dishwasher safe (e.g., the ability to withstandabout 15 minutes at least at about 50 degrees Celsius, or more narrowlyat least about 75 degrees Celsius, or more or less, withoutsubstantially noticeable deformation, deterioration, or other damage,and lack of substantial deterioration or other substantial damage fromsimilarly extended exposure to water and typical dishwasher detergents).

a. Flexible Tip

The flexible tip 18 (i.e., nozzle or catheter) may be integral with thehead 14, or may be a separate removable and/or replaceable and/ordisposable component, as shown. The flexible tip 18 is desirably sizedand configured to be placed adjacent to, or inserted wholly or partiallyinto, a biological orifice or surface to be irrigated and/or aspirated.For example, the flexible tip 18 can be configured to fit wholly orpartially into a nostril (see FIG. 5A), and its flexibility allows formovements of the device 2 and/or movements of the patient. The flexibletip 18 can have a pointed conical, rounded conical, nippled, bulbous,mushroom cap, or waisted configuration, or combinations thereof. Theflexible tip 18 may include a flexible stem 80, and/or sealing means,such as an o-ring 86 as shown.

In an exemplary embodiment, FIG. 16 illustrates that the distal portionof the flexible tip 18 can be configured to include a bulbous ormushroom capped shape portion 82. The distal portion of the flexible tip18 can be bulged or waisted. The flexible tip 18 can have a largerradius proximal to the distal end 84, for example, to preventover-insertion of the tip 18 into a natural body orifice.

The tip 18 can be configured to make a positive seal with the irrigationand/or aspiration site (e.g., the nostril), as seen in FIG. 5B. Thedistal flexible portion 82 provides the temporary seal with the nostril,allowing for both irrigation (identified with arrow 32) and aspiration(identified with arrow 42) to take place through the respectiveirrigation channel 36 and aspiration channel 46.

The tip 18 can seal to the irrigation and/or aspiration site analogousto a ball and socket joint and/or similar to nested tubes. The flexibletip 18 can be rotationally symmetric about a longitudinal axis of thehead 14. The rotational alignment can be decoupled from the sealingfunctionality, for example allowing one more degree of freedom for theuser.

The flexible tip 18, and/or all or some of the head 14 can be made fromand/or covered or coated with a compliant material such as siliconerubber or foam, and/or medications, and/or lubrications. The flexibletip 18, and/or all or some of the head 14, i.e., components that maytouch the patient, may be removable and/or replaceable and/ordisposable. The flexible tip 18 can be compliant, for example, to permitsealing to differently-shaped nostrils, and may include lubrications toenhance sealing. The flexible tip 18 can be sufficiently rigid to notdeform against the negative pressure of the aspiration.

FIGS. 17 and 18 illustrate the flexible tip 18 includes a distal end orface 84 for the passage of fluids (e.g., for either or both irrigationand aspiration). The distal face 84 is shown to comprise both anirrigation port 34 and an aspiration port 44. It is to be appreciatedthat the aspiration port 44 and the irrigation port 34 can be at theouter surface of the flexible tip 18 and/or the aspiration port 44and/or the irrigation port 34 can be recessed within the flexible tip18. It is also to be appreciated that, in an alternative embodiment, theflexible tip 18 can have one or more irrigation ports 34 and/oraspiration ports 44.

As shown, the irrigation port 34 can be located adjacent to theaspiration port 44 (see FIG. 17). The irrigation port 34 can becompletely or partially surrounded by the aspiration port 44 (see FIG.18). The aspiration port 44 can be completely or partially surrounded bythe irrigation port 34.

b. Irrigation and Irrigant Reservoir

As seen in FIG. 19, the irrigant reservoir 30 is shown to be in directfluid communication with the irrigant port 34, via the irrigationchannel 36. In an alternative embodiment, the head 14 can have one ormore irrigation ports 34 (see FIG. 20). The irrigation port 34 can beconfigured to dispense or otherwise discharge the irrigation fluid 32.The irrigation port 34 can be configured to dispense or otherwisedischarge the irrigation fluid in an atomized configuration, forexample, by mixing the irrigation fluid 32 (e.g., in a liquid state)with an atomizing gas, and/or passing irrigation fluid 32 through anatomizer 88. The irrigation fluid 32 may be heated (e.g., electricallyheated via the power source 6) to provide an irrigation fluid 32 at ornear the body temperature to provide additional comfort for the patient.

The flexible tip 18 is shown to include the flexible stem 80. The stem80 (and flexible tip 18) may comprise the irrigation channel 36. Theirrigation channel 36 may also be a component of the irrigant reservoir30, or a separate component, or any combination. The stem 80 of theflexible tip may be positioned in fluid communication with the irrigantreservoir 30 via an irrigant reservoir port 35.

The irrigation channel 36 can have an irrigation channel diameter 38.The irrigation channel diameter 38 can be the minimum internal diameterof the irrigation channel 36. The irrigation channel diameter 38 can beless than about 1 cm (0.4 in.), more narrowly less than about 2 mm (0.8in.), for example about 0.7 mm (0.03 in.), or more or less.

The irrigation channel 36 can have an irrigation channel lining 136. Theirrigation channel lining 136 can actively (e.g., can be movable, suchas an electro-active polymer skin) or passively (e.g., by the shape ofthe channel lining 136) focus the exiting stream of irrigant 32. Theirrigation channel lining 136 can form a venturi 138 in the irrigationchannel 36. The irrigation channel lining 136 can be integral with, orfixedly or removably attached to the irrigation channel 36.

In use, a force may be applied, such as via pump 11 and user controls 10(to be described in greater detail below) to the flexible irrigationplug 28 adjacent to and/or coupled to the irrigant reservoir 30. Theforce produces an irrigant pressure 39, causing irrigant 32 to flowthrough the irrigation channel 36, out the irrigation port 34, and intothe desired cavity.

The irrigant reservoir 30 may comprise a variety of shapes and can beintegral or fixedly or removably attached to the head 14 and/or the body4. The irrigant reservoir 30 can hold irrigant 32. The irrigantreservoir 30 can be a replaceable cartridge or ampoule. The irrigantreservoir 30 may comprise a compressed gas and irrigant 32. The irrigantreservoir 30 can be removable, disposable, replaceable, recyclable, orcombinations thereof. The irrigant reservoir 30 can be pre-filled withirrigant 32 or ready for adding all or a component (e.g., water) of theirrigant 32. The irrigant reservoir 30 can be divided into multiplesub-reservoirs. For example, one sub-reservoir can have salt and anotherirrigant reservoir can have water. The sub-reservoir contents can mix(e.g., creating saline solution) when the irrigant is dispensed.

The irrigant reservoir 30 can be the same volume, a larger volume than,or a smaller volume than the aspirant reservoir 40. For example, theaspirant reservoir 40 volume can be about 100 or less times larger thanthe irrigant reservoir 30 volume, or more narrowly, about 20 or lesstimes larger than the irrigant reservoir 30 volume, or more narrowly,about 7 or less times larger than the irrigant reservoir 30 volume, ormore narrowly, about 3 or less times larger than the irrigant reservoir30 volume, or more narrowly about 1.5 or less times larger than theirrigant reservoir 30 volume, for example the aspirant reservoir 40volume can be about 1.25 times the irrigant reservoir 30 volume. Theirrigant reservoir 30 volume can be, for example, about 10 mL, or morenarrowly about 5 mL, or more narrowly about 3 mL, or more or less.

The irrigant reservoir 30 can be a first color (e.g., blue), theaspirant reservoir 40 can be the first color or a second color (e.g.,yellow or red). The irrigant reservoir 30 and/or aspirant reservoir 40can be transparent, translucent or opaque. The irrigant reservoir 30 canseat into the head 14 in a different configuration than the aspirantreservoir 40. For example, the irrigant reservoir 30, aspirant reservoir40, and the remainder of the head 14 can be configured so as to not beable to insert the irrigant reservoir 30 in the head 14 in place of theaspirant reservoir 30 and/or vice versa.

The irrigation fluid or irrigant 32 can have or be water, salinesolution, zinc solution (e.g., zinc sulfate solution), alcohol,anesthetic agent, analgesic agent, antipyretic agent, anti-inflammatoryagent such as a non-steroidal anti-inflammatory agent (e.g., ibuprofen,aspirin, salicylic acid, COX02 inhibitor, COX-3 inhibitor),acetaminophen, vaccines (e.g., live attenuated flu vaccine, FLUMIST®),antihistamine (e.g., azelastin hydrocholoride), corticosteiroid (e.g.,fluticasone propionate), topical decongestant (e.g., oxymetazolinehydrochloride), vitamin (e.g., vitamin c, ascorbic acid), nicotine,herbal medicines, powders, other therapeutic or diagnostic medication,or combinations thereof.

The irrigant 32 can combine with an atomizing gas and/or atomizer 88.The tip 18 may be configured to atomize the irrigant 32. The atomizinggas can have or be, for example, air, carbon dioxide, oxygen, nitrogen,nitrous oxide, another anesthetic, or combinations thereof.

Atomized irrigant 32 can include particles having a diameter from about0.1 micrometre (0.004 mil) to about 100 micrometre (4 mil) upon exitfrom the tip 18. The atomized irrigant 32 particles can have a highmobility and can substantially uniformly coat and/or adhere and interactwith the target site, tissues, and fluids.

The head 14 (and/or the control 10 and/or pump 11, for example) may beconfigured to provide various irrigant 32 flow characteristics. Forexample, the device 2 can be configured to produce flood (e.g., in anunbroken, or unhollow stream, or shower-like, or substantiallycylindrical stream, for example), and/or atomize, and/or conical (e.g.,hollow or unhollow conical stream, for example) irrigationcharacteristics. The flow characteristics can be automatically ormanually adjusted. The flexible tip 18 or head 14 can be manuallyreplaced with a differently configured tip 18 or head 14 to change theirrigation characteristics.

The irrigant 32 can be delivered as one or more unatomized floods orstreams or flows without the mixing with an atomizing gas, or passingthrough an atomizer 88. For example, the device 2 can have no atomizinggas or atomizing region or other atomization elements.

FIG. 21 illustrates that the irrigant 32 can be refilled. The irrigantreservoir 30 can have an irrigant reservoir seal 140 against the wall ofthe irrigant reservoir 30. For example, the irrigant reservoir seal 140can be plastic. The irrigant reservoir seal 140 can be self sealingand/or manually controlled to open and close.

The external irrigant container 56 can have fresh irrigant 32. Theirrigant container 56 can have a container spout 57 configured to insertinto the irrigant reservoir 30 through the irrigant reservoir seal 140and/or the irrigation port 34. The irrigant container 56 can be advancedinto the irrigant reservoir seal 154 or port 34, as shown by arrow. Thecontents of the irrigant container 56 can then be deposited into theirrigant reservoir 30, for example by squeezing the irrigant container56 and/or by opening a pressure release port (not shown) on the irrigantcontainer 56. The irrigant 32 in the irrigant container 56, and acompressed gas, can then be transferred into the irrigant reservoir 30.The irrigant container 56 can then be removed from the irrigantreservoir seal 154 or port 34 and the irrigant reservoir seal 140 canclose.

c. Aspiration and Aspirant Reservoir

In addition to those features of irrigation and aspiration, and theirrigation reservoir 30 and aspiration reservoir 40 described above, theaspiration reservoir and aspiration function may include additionalfeatures. In some embodiments, the aspiration reservoir 40 may be indirect fluid communication with the aspiration port 44, via theaspiration channel 46 (see FIG. 19).

As previously described, the flexible tip 18 is shown to include thestem 80. The stem 80 (and flexible tip 18) may comprise the irrigationchannel 36 and/or the aspiration channel 46. The aspiration channel 46may also be a component of the aspirant reservoir 40, the head 14, or aseparate component, or any combination. The stem 80 of the flexible tip18 may be positioned in fluid communication with the aspirant reservoir40 via an aspirant reservoir port 45.

The aspiration channel 46 can have an aspirant channel diameter 48. Theaspirant channel diameter 48 can be the minimum internal diameter of theaspirant channel 46. The aspirant channel diameter 48 can be less thanabout 1 cm (0.4 in.), more narrowly less than about 5 mm (0.2 in.), forexample about 3 mm (0.12 in.), or more or less.

In some embodiments, the aspiration port 44 can have an inflow check(i.e., one-way) valve 130 for inflow configured to substantially orcompletely prevent backflow of aspirant 42 from the aspiration channel46 or reservoir 40. The inflow check valve 130 can be or have a ballvalve, swing valve, clapper valve, umbrella valve, double check valve,duck bill valve, or combinations thereof. The inflow check valve 130 canbe integral or fixedly or removably attached to the aspiration port 44and/or the aspiration channel 46 and/or the aspirant reservoir 40.

The aspirant reservoir 40 may comprise a variety of shapes and beintegral or fixedly or removably attached to the remainder of the device2. The aspirant reservoir 40 can hold aspirant 42. The aspirantreservoir 40 can be a replaceable cartridge or ampoule. The aspirantreservoir 40 may comprise a pressure, e.g., a vacuum. The aspirantreservoir 40 can be removable, disposable, replaceable, recyclable, orcombinations thereof. The aspirant reservoir 40 can be divided intomultiple sub-reservoirs. In some embodiments, vanes and/or baffles mayused to create multiple sub-reservoirs to provide barrier means 24 toblock the flow of mucus, but allow the flow of air. In some embodiments,multiple sub-reservoirs may be used to provide a desired mucus sample tothe diagnostic means 22.

In use, a pressure (i.e., vacuum) is applied via controls 10 (to bedescribed in greater detail below), to the aspiration reservoir 40. Thevacuum produces a negative aspirant pressure, causing aspirant 42 toflow as shown by arrows from the treatments region, through aspirationport 44, through the aspiration channel 46, and into the aspirationreservoir 40, where it collects. As previously described, the barrier 24is configured to allow the passage of gas exchange (e.g., air) andexcludes the passage of liquids (e.g., irrigation fluid and mucus),maintaining separation of aspirant 42 from the body 4.

d. Diagnostic

The ability to have hands-off specimen collection and analysis is evermore important as focus on infectious disease control increases. Thedevice 2 may be adapted to provide this important function. For example,nasal specimen delivery to an embedded diagnostic means 22 (e.g.,detection platform) in the head 14 and/or body 4 may incorporate avariety of platforms, including, but not limited to:

1.) Lateral Flow immunochromatographic assay, such as those commonlyused now for respiratory viral detection, (e.g., RSV, influenza);

2.) Electrochemical detection microarray chips, that when exposed to asource of power, such as power source 6 provided to the head 14 viacontact points, for example, produces biomolecular markers in situ whichcan themselves be labels for the genetic material in viruses, bacteria,and fungi, for example. It may also involve using enzymatic reactions togenerate electrical signals that can be read directly from/on the assay.Alternatively, a separate reader dock with appropriateelectrical/photometric specifications may be used for organismidentification in the head 14. The reader dock may comprise astand-alone device, or may be incorporated into the charging base 62,for example.

3.) Microfluidic tmRNA purification combined with nucleic acid sequencedbased amplification (NASBA) that incorporates real-time detection usingmolecular beam fluorescent probe technology. This may be impregnated ona chip and if a power source is needed, power source 6 may provide powerto the head 14 via contact points, for example. In addition, there maybe a contact in the head 14 that is activated by a separate “labactivating” button on the head 14 or body 4, for example.

4.) “Biosensor” technology may also be embedded into the head 14 and maycomprise a genetic plate coated with one or several antibodies to thetarget organism. When combined with a reagent and theorganism-containing specimen and then exposed to light, it makes avisible color change so that no external source is needed to detect theorganism.

5.) Other known or future developed bioassays which offer organismdetection or chemical analysis on a chip and/or strip and/or geneticplate, and/or with a chemical, for example, may be placed in the head 14and/or body 4 for hands-off laboratory handling of specimens.

Delivery of these specimens to the above mentioned detection platformsdesirably would not require handing, but rather may be delivered in theexact needed quantities using pressure means, e.g., the device's pump,to guide the specimen into pressure sensitive traps/portals which maythen communicate with the testing platform at the precise location forappropriate delivery. This action or process may occur only when thehead is in a certain position and/or when the nozzle is completelyoccluded, for example.

Alternatively, the specimen could be delivered to the testing platformby manual means in which the collection chamber is gently agitated andan inside smaller chamber is thereby filled with a predetermined neededaliquot to be presented to the testing platform. This final delivery maybe initiated by pressing or popping a flexible portion, e.g., a“blister,” and/or a spring-loaded piston, and/or a button, on the sideof the head 14, which then opens previously closed fluid communicationsfrom the aliquot chamber to the testing platform, providing hands-offpippeting.

Alternatively, the specimen could simply fill into a predeterminedsmaller chamber open to the rest of the collection chamber. A portion ofthe testing platform may extend into this smaller chamber but the restof the testing platform may be sealed off and separated by apolypropylene wall, for example. The specimen may then travel into therest of the testing platform via wicking, e.g., lateral flowimmunochromatography, capillary action, e.g., microfluidic capillaryaction, electrical charge, and/or an opening of the separating wall byway of a blister breaking point, membrane, or seal, as non-limitingexamples.

The device 2 including the diagnostic means 22 is well suited forhospital and clinic use, as well as self diagnosis in the home. Thedevice 2 including the diagnostic means 22 may be used in medicine fordetecting all types of microorganisms, in warfare for weaponizedbacteria, agents, and viruses, in emergency services, in high volumetravel sites such as airports to detect infected travelers and inschools and daycares to define infected students. The device 2 includingthe diagnostic means 22 may also house testing platforms which detectlabs such as metabolic panels, glucose, insulin levels, drug levels,b-natiuretic peptide, d-dimers, and CRP from the gathered specimen.

After use (i.e., aspiration), the head 14 and/or aspirant reservoir 40may contain contaminated fluids such as irrigant and mucus (i.e.,aspiration fluid 42). The irrigant reservoir 30 and/or the aspirantreservoir 40, and/or the entire head 14, or other components of the head14 or body 4, may then be used, and/or removed for use, as a diagnosticdevice to test and/or evaluate the contaminated fluids for disease ormedical conditions such as injuries, disabilities, disorders, syndromes,infections, and/or viruses, for example. If removed, the component(s)removed may be sealed to avoid cross contamination. Access may beprovided to allow lab personnel access to the fluid 42 to be tested.

In some embodiments, the head 14 and/or the aspirant reservoir 40, forexample, may include the diagnostic means 22, such as those previouslydescribed, or any combination, as non-limiting examples (see FIGS. 22Athrough 22C). The diagnostic means may be imbedded in the head 14, oraspirant reservoir 40, or the body 4, or may be a removable componentfor further testing and/or evaluation. The diagnostic means 22 mayprovide immediate results or the head 14 and/or diagnostic means 22 maybe sent to a lab for further action.

The diagnostic means 22 may comprise a testing platform or an analysissystem 90, such as a lateral flow test strip analysis system (i.e.,immunochromatography), and/or a micro total analysis system (i.e., labon a chip), for example, and may incorporate microfluidics includingmechanical flow control devices like pumps and valves or sensors likeflow meters and viscometers. The lab on a chip may be made of glass,silicone, ceramics, or metal, for example.

The device 2 and diagnostic means 22 may simplify and provide hands-offgathering of a specimen by reducing the testing process to nasalsuctioning with the device 2 using the aspiration function, andpresenting a predetermined amount of the aspirated fluid sample 42 tothe diagnostic means 22. Once the sample 42 has been presented to thedevice 2, e.g., is within the head 14, the sample may be presented tothe diagnostic means 22 either manually (e.g., pressure applied), orautomatically (e.g., solenoid driven). In some embodiments, the sample42 may be drawn into a sample collection well, or capillary, or chamber92, for example, such as by shaking the head 14 (or the device 2) so asto draw the fluid sample 42 into the chamber 92, or by capping theflexible tip 18 with the cap 20, or finger 76, actuating the aspirationfunction again so as to cause an occluded suction, which draws theaspiration fluid sample 42 into the chamber 92. Once the sample iswithin the chamber 92, it may be available to the analysis system 90 fortesting. The chamber may provide a predetermined volume of fluid sample42 to the analysis system 90.

Once in the chamber 92, the predetermined volume of sample 42 may thenbe automatically presented to the analysis system 90, or an action maybe necessary, such as manually popping a blister 94, or the push of abutton, or movement of a switch, on the side of the head 14, forexample, to allow entry of the sample into and/or onto the analysissystem 90.

In some embodiments, there may be one or more chambers in fluidcommunication with the diagnostic means 22 whose arrangement andcommunication with the sample collection chamber 92 allows apredetermined test sample size to be drawn. The test sample may becombined with a reagent from one or more of the chambers to form analiquot to then be delivered to the analysis system 90.

In some embodiments, the diagnostic means 22 may then display and/orpresent a result or results of the test(s). For example, the results maybe displayed as a change of color of an indicator 95 on or in thediagnostic means 22 and/or head 14, or a test strip 96 may be removedfrom the diagnostic means, or visible within the head 14 and/oraspiration reservoir 40, for example An electrical contact 97 may beincluded to provide electrical power to the diagnostic means 22.

The diagnostic means 22 may accommodate microbiologic tests including,but not limited to: influenza A and B, avian flu, RSV (respiratorysyncytial virus), adenovirus, Legionella, CNV, EBV, Group A betahemolytic streptococcus, S. pneumoniae, N. meningitides, mycoplasma,Staphloccus aureus, Malaria, HIV, rhinovirus, coccsackie virus,smallpox, anthrax, botulinum toxin, ricin, ebola, rabies, brucellosis,(plague) yersinia pestis, coxeilla burnetti (Q fever), T2 mycotoxins,francisella tularensis (tularemia), viral equine encephalitis, viralhemorrhagic fever, and burkholdria mallei (glanders).

The diagnostic means 22 may accommodate toxicologic and/or chemicaltests including, but not limited to: amphetamines, cocaine, opiates,phencyclidine, tetrahydrocannabinol, acetaminophen, barbiturates,benzodiazepines, methadone, propoxyhenone, tricyclic antidepressants,calcium channel blockers, ethyl alcohol, ethylene glycol, ketones,glucose, hypoglaecemics, cytokines, interleukins, insulin, HemoglobinA1C, electrolytes, human choreonic gonadotropin (pregnancy test),thyroid-stimulating hormone (TSH), T3 blood test, T4 blood test,c-reactive protein (CRP), and erythrocyte sedimentation rate (ESR).

The diagnostic means 22 may include real time polymerase chain reactiontests and/or immunoassays for viruses, bacteria, and cancers, forexample.

B. Power Source

According to one desirable technical feature, the device 2 can have apower source 6. FIG. 23 illustrates the power source 6 can be storedcompletely or partially in a compartment, for example, a power sourcecompartment within the body 4. The power source 6 may comprise anelectrical power source (e.g., a battery or capacitor), and/or amechanical power source (e.g., a flywheel or spring for energy storage),and or a compressed gas (e.g., a canister of compressed gas), asnon-limiting examples. In some embodiments, the power source 6 is arechargeable power source. The rechargeable power source may benon-removable (i.e., the device 2 is placed on or in a power sourcerecharger 62), or the rechargeable power source may be removed to berecharged and/or replaced.

The recharger 62 and/or the base 4 may include a direct, or sealed, orinductive coupling region 98, 99 respectively, for example, to allow thedevice 2 to be electrically and/or mechanically coupled to the rechargerfor recharging (see FIGS. 23 and 24). The recharger 62 may also be arechargeable device, and/or the recharger may be coupled to an externalsupply of electricity (e.g., 120 VAC electrical wall outlet). Therecharger 62 may include an illumination source or light 100 (e.g.,LED), to provide indications, such as power on, recharging, andrecharged, as non-limiting examples, and may be placed on a surface,e.g., desk or counter top, or mounted to a wall. As previouslydescribed, the recharger 62 may incorporate a reader dock withappropriate electrical/photometric specifications that may be used fororganism identification in the head 14, as part of the diagnostic means22. Alternatively, the reader dock may comprise a stand-alone device,and/or may draw power from the recharger 62.

In an alternative embodiment, the power source 6 may include one or morenon-rechargeable electrical cells (e.g., one or more batteries), forexample, four AA alkaline batteries in series, as a non-limitingexample.

In some embodiments, the power source 6 may comprise a Lithium Ion powersource, and may be configured to supply about 100 mAh, or about 500 mAh,or about 750 mAh, or about 1000 mAh, or more or less, at about 7.4volts, although it is to be appreciated to one of skill in the art thatthe power source 6 may be configured to supply a wide range of voltagesand capacities. The power source 6 desirably possesses a capacitysufficient to allow operation with recharging and/or power sourcereplacement not more frequently than once per five minutes, or fifteenminutes, or thirty minutes, or hour, or day, or week, or month, or year,for example, for many or most applications. The power source 6 can alsobe configured to connect to an external supply of electricity (e.g., a120 VAC electrical wall outlet).

The power source compartment can be accessible from outside of the body4 through a power source compartment door (not shown). The power sourcecompartment door can be removably attached to the body 4. The powersource compartment door can be hingedly attached to the body 4.

The power source 6 may be electrically coupled to an illumination sourceor light 102 (e.g., LED), to provide indications, such as power on,power supply capacity, and irrigation and/or aspiration functionsactivated, as non-limiting examples.

C. Device Controls

According to one desirable technical feature, the device 2 can have acontrol 10 that can be configured to provide multiple functions (seeFIG. 25). The control may comprise buttons, switches, triggers, levers,electrical circuitry, interaction between any of these, and may includemicroprocessor control 110, as non-limiting examples. The control 10 canenable user-induced, and/or automated actuation of the device 2. Forexample, the device 2 may be actuated by contact with the area to beirrigated and/or aspirated, e.g., a nostril. The control 10 can becoupled to a dual function switch, or one or more multiple-functionswitches, or one or more single-function switches, or combinationsthereof, as non-limiting examples. The switch(s) 112 may comprisebuttons, rockers, toggles, triggers, or other known configurations andcombinations, and may be attached to or integral with the body 4 and/orhead 14, or combinations thereof.

The control 10 can manually (e.g., user-induced) or automatically (e.g.,electrically, pneumatically, stored energy) actuate and/or power and/orotherwise control, either directly or indirectly, the irrigation and/oraspiration functions. The control 10 may be adapted to provide variablecontrol of irrigation and/or aspiration, and may include the ability toprovide a delay, such as an adjustable delay, for irrigation and/oraspiration. The control 10, including the switch 112, can be simple andintuitive to use.

The control 10 (or other elements) can be used to transmit power fromthe power source 6 to activate electronics (e.g., the pump 8, motor 9,and/or microprocessor 110), valves, manually pump, or any combinationsthereof. The control 10 can be configured to receive input from the oneor more buttons 112.

FIGS. 26 through 29 show an exemplary embodiment for methods of use ofthe device 2. As seen, the control 10 can produce a first input, forexample a pressing translation 114 of the button 112. The control 10 canproduce a second input, for example, a pressing translation 116 of theswitch 112 that is not the first input. The first input can control theirrigation, for example whether irrigant is manually expelled from thehead 14, and/or the frequency and/or volume of the irrigation flow. Thesecond input can control the aspiration, for example whether aspirationis on or off and/or the intensity of the pressure and/or flow rate ofaspiration.

In an alternative embodiment, the control 10 can receive a first input,for example a pressing translation 114 of the button 112. The control 10can receive a second input, for example, a pressing translation 116 ofthe button 112 that is not the first input. The first input can controlthe irrigation, for example whether irrigant is automatically expelledfrom the head 14 (i.e., on or off) and/or the intensity of the pressureand/or flow rate of the irrigant and/or the frequency of the irrigantflow. The second input can control the aspiration, for example whetheraspiration is on or off and/or the intensity of the pressure and/or flowrate of aspiration.

FIG. 26 illustrates that a user can ergonomically hold the body 4 in asingle hand. The user can rest a finger 76 or thumb 77, for example, onthe button 112, allowing the button 112 to be operated by a single digit(i.e., finger 76 or thumb 77). The palm 74 and/or other fingers 76 cansubstantially or completely rest on the grip pads 78.

By way of example, FIG. 27 illustrates that the thumb 77 can press afirst portion of the button 112, as shown by arrow 114. The pressing 114of the button can control the other of the irrigation and/or aspirationnot controlled by the pressing 116. As shown for example, pressing thebutton 112 can actuate the device 2 to create a pressure resulting in apressured fluid delivery resulting in the irrigant flow 118. Releasingthe pressing 114 of the button 112 can stop the pressurized fluiddelivery. The inward distance the button 112 is pressed 114 can directlyor indirectly correlate to the pressure and/or volume of the aspirationor irrigation.

By way of example, FIG. 28 illustrates that the thumb 77 can press asecond portion of the button 112, as shown by arrow 116. The pressing116 of the button 112 can control irrigation and/or aspiration. As shownfor example, pressing the button 112 can actuate the device 2 to createa suction resulting in aspirant flow 120, as shown by arrow 120.Releasing the pressing 1164 of the button 112 can stop the suction andaspirant flow. The inward distance the switch 112 is pressed 116 maydirectly or indirectly correlate to the pressure and/or volume of theaspiration or irrigation.

By way of example, FIG. 29 illustrates that the thumb 77 can press boththe first portion and the second portion of the button 112, as shown byarrow 114 and arrow 116, so as to concurrently depress the first portionand the second portion of the button 112. Pressing 114 the first portionof the button 112 and pressing 116 the second portion of the button 112concurrently can actuate the device 2 to create a pressured fluiddelivery resulting in the irrigant flow 118, and concurrently resultingin a suction causing an aspirant flow 120.

Alternatively, the thumb 77 can alternate pressing the first portion andthe second portion of the button 112, by rocking back and forth between114 and 116, or 116 and 114. Pressing 114 the first portion of thebutton 112 and pressing 116 the second portion of the button 112 with arocking motion can actuate the device 2 to create a pressured fluiddelivery resulting in the irrigant flow 118, and then stepwise resultingin a suction causing an aspirant flow 120.

In an exemplary embodiment illustrated in FIG. 25, button 112 cancomprise a first switch 122 configured to control, for example via thepump 8, pressure in the aspiration channel 46 (i.e., aspirationpressure). The first switch 122 may comprise a variable switch adaptedfor control of the aspiration function, including whether aspiration ison or off and/or the intensity of the pressure and/or flow rate ofaspiration. The button 112 can have a second switch 124 configured tomanually actuate a second pump 11 to deliver pressure, either directlyor indirectly, to the irrigant reservoir 30 and irrigation channel 36.The second switch 124 may comprise one or more elements 176, 178 adaptedto translate movement from the button 124 (e.g., by pressing) to thepump 11, so as to result in a pressured fluid delivery resulting in theirrigant flow 118. As previously described above in relation to thebutton 112, the first switch 122 can be activated by a first digit(e.g., the thumb 77), and the second switch 124 can also be activated bythe first digit (e.g., the thumb 77), or a second digit (e.g., the indexfinger 76), for example, to provide individual or concurrent control andoperation of the irrigation and/or aspiration functions.

It is to be appreciated that one or more buttons can control theaspiration (i.e., suction) and irrigation with one digit (i.e., finger77 or thumb 78). The button 112 can be configured to receive multipleinput signals (e.g., from the user). The button 112 can have one, two ormore degrees of freedom. For example, the button 112 can receive apressing translation, and/or a sliding translation, or combinations. Thecontrol 10, via the multiple input signals (e.g., pressing and sliding),can be configured to separately control (e.g., binary/two-state control(on/off) and/or variable control of the magnitude of power to graduallyincrease or decrease, as non-limiting examples) the aspiration and theirrigation. For example, one input signal (e.g., pressing or sliding orboth) can control the aspiration and another input signal (e.g.,pressing or sliding or both) can control the irrigation. The sliding canbe along the longitudinal axis of the body 4 and/or head 14. Thepressing can be orthogonal to the sliding, as a non-limiting example.

The button 112 can be bi-functional. The button 112 can have a rockerplatform that can encase a variable speed switch to provide variablecontrol of irrigation and/or aspiration. The variable speed switch canbe moved from an off setting to a maximum speed (and/or on/off) settingby sliding the variable speed switch along the platform. The platformcan be flush with, inside, or outside the device 2 case 5. The platformcan be hinged at a first end and free at a second end. The platform canbe resiliently pressed toward the remainder of the device 2, forexample, over a balancing spring. Pressing the platform can manuallyactuate, or activate automatic actuation of, irrigation and/oraspiration.

D. Pumps

According to one desirable technical feature, the device 2 can have oneor more pumps 8 and 11 that can be configured to provide a pressure. Thefirst pump 8 can produce a different or the same flow rate and/orpressure as the second pump 11.

In some embodiments, the pump 8 can be, for example, a piston pump, arotary vane pump, a linear pump, and/or diaphragm pump (i.e., a membranepump, positive displacement pump), such as a dual diaphragm pumps 8, asshown in FIGS. 30 through 32. The pump 8 may have at least twooppositely-oriented oscillating shafts, rods, or membranes. In otherembodiments, the pump 8 can be or have a compressed gas (e.g., air,carbon dioxide, nitrogen) canister 210 that can be configured tocontrollably store and release the compressed gas.

The pump 8 can be connected to or interface with the control 10,directly or indirectly through the motor 9. The motor 9 may be chosen tobalance a desired rpm with an acceptable current draw. As previouslydescribed, the control 10 may include a microprocessor 110 configured toregulate and/or vary the motor speed to control irrigant deliverypressure and/or aspirant suction pressure. The aspirant suction pressurecreated by the pump 8 can be, for example, up to about 200 mm Hg (3.86psi), or more narrowly about 120 mm Hg (2.32 psi), or more narrowlyabout 80 mm Hg (1.55 psi), or more narrowly about 50 mmHg (0.966 psi),or more or less. The control 10 can receive one or more inputs from thebutton 112. The microprocessor 110 can analyze the button position tocontrol the motor speed. As previously described, the pump 8 and/orcontrol 10, may incorporate a valve 128 or control algorithm to limitthe aspirant suction pressure to about 100 mm Hg, for example.

The pump 8 can have doubled-up diaphragms, as a non-limiting example.The pump 8 can be manually and/or electrically powered. The pump 8 canbe attached to an AC or DC-driven motor 9. The pump 8 can be driven bymotor 9 that can be driven by the power source 6. The pump 8 can haveone or more blowers, turbines, fans, diaphragms, bellows, orcombinations thereof.

An exemplary embodiment of the pump 8 can be seen in FIGS. 30 and 31.Pump chassis 150 houses two oppositely-oriented oscillating diaphragms.For simplicity, the configuration of one side of the pump 8 will bedescribed (i.e., a left side), with the other side being a mirror image(i.e., a right side). It is to be appreciated that both sides of thedouble diaphragm pump need not be mirror images. Within the pump chassis150 resides a throw pin 152, with a diaphragm arm 154L rotatably coupledto the throw pin 152. The diaphragm arm 154L comprises an optimizeddiaphragm arm height H. The diaphragm arm height H is shown to bemeasured from the center of the diaphragm arm throw pin shaft hole 153to the top surface of the diaphragm 156L, and may include a length ofabout 4 to 8 mm, or more narrowly about 5 to 7 mm, or more narrowlyabout 6.5 mm, or more or less. The shorter the diaphragm arm height, themore the diaphragm 156L undesirably “rocks,” and the longer thediaphragm arm height, the size of the pump increases. The diaphragm armheight may be advantageously reduced as much as possible, with thelimitation of shortening the diaphragm arm height relating directly tothe diaphragm diameter D and how much rocking the diaphragm does perstroke.

Advantageously, the diaphragm 156L may also be optimized with a diameterD and a generally “M” or “S” cross-sectional shape to most efficientlyaccommodate the rocking motion (see FIG. 31), and to push a majority ofthe air out and pull a majority of the air in for each stroke. Thediaphragm 156L may be sandwiched between the diaphragm arm 154L and adiaphragm plate 158L. The diaphragm 156L comprises an optimized diameterD, and may include a diameter of about 20 to 40 mm, or more narrowlyabout 25 to 35 mm, or more narrowly about 30 mm, or more or less, thediameter D 156L providing an optimized flow per stroke. The optimizeddiameter D allows the pump to fit within the base 4 and allows the pumpto operate at the lowest possible RPM while providing desired flowrequirements. The diaphragm plate 158L provides a rigid center region ofthe diaphragm 156L. The diaphragm plate 158L also improves efficiency byhelping to ensure that all the air is pushed out and pulled in for eachstroke. Without the diaphragm plate 158L, the diaphragm 156L may insteadmerely stretch and/or flex.

A diaphragm chamber 161L may be seated on or adjacent to the diaphragm156L, with an intake one-way umbrella valve 159L and an exhaust one-wayumbrella valve 163L positioned on respective sides of the diaphragmchamber 161L. The use of the one-way umbrella valves and the diaphragmchamber help to minimize the thickness of the pump 8. A manifold gasket165L and a pump manifold 164L may be mounted to the chassis 150, and anexhaust hose 166L and/or intake hose 170L may be coupled to the manifold164L. Again, this or a similar configuration is repeated on the otherside of the pump 8. The intake hose 172 may then extend through the body4 to the aspiration aperture 192. The throw pin 152 may be coupled tothe motor 9 to provide oscillating movement of the oppositely-orientedoscillating diaphragms.

Large diaphragms with high throw produce a desired high flow with lowvolume. Due to a physical limitation of space within the defined base 4,the ability to increase the diameter of the diaphragm may be limited. Inorder to provide the desired high flow with low volume, theconfiguration of the diaphragm 156L having a diameter D sandwichedbetween the diaphragm arm 154L having a height H, and the diaphragmplate 158L may be optimized to provide the improved high level of flowwith a high level of oscillation or throw. The relationship between thediameter D and the height H may be expressed as the ratio of D/H, wherethe ratio may be from about 2/1 to about 10/1, and more narrowly about4/1 to about 6/1, and more narrowly about 5/1, or more or less. Theimproved performance of such a device was not possible in prior devices.

In some embodiments, displacement may be maximized by using the doublediaphragm configuration as described, increasing the rpm of the pump 8only high enough to meet flow requirements, and including the uniquediaphragm with the distinct shape and diameter to allow increased flowper stroke, as previously described.

The pump 8 can have a total volume. For example, the pump 8 can have avolume of about 100 cc (6.1 in³), more narrowly about 75 cc (4.6 in³),and more narrowly about 50 cc (3.05 in³), or more or less.

FIG. 32 shows an alternative embodiment of the pump 8. The alternativeembodiment is similar to the pump 8 as shown in FIGS. 30 and 31, exceptthe diaphragm chamber 160L interfaces with a flat valve 162L.

An exemplary embodiment of a pump 11 can be seen in FIGS. 33 and 34. Thepump 11 can be connected to or interface with the control 10, directlyor indirectly through the button 112 and/or switch 124. One or morepivot arms, such as a first pivot arm 177 and a second pivot arm 178 maybe induced into pivotal motion to apply a force 180 either directly orindirectly to the irrigation reservoir 30, e.g., through the irrigationbellows 68. Mounting plate 182 may provide a first pivot point 184 forthe first pivot arm 177, and a second pivot point 186 for the secondpivot arm 178. In some embodiments, the non-pivot end 188 of the secondpivot arm 178 may extend partially or completely through an irrigationaperture 190 in the mounting plate 182 (see also FIG. 8C). The button112 may be pressed or pushed 114 by the user to translate the downwardmotion 114 into the force 180, through the interface region 13, and uponthe bellows 68 by the non-pivot end 188 of the second pivot arm 178. Ascan be seen, an aspiration aperture 192 provides a path for aspirationvacuum 49 to pass through the interface region 13 and extend from thehead 14 to the base 4.

E. Flow Diagrams

According to one desirable technical feature, FIGS. 35A and 35Billustrates that the device 2 may be adapted to provide partial orcomplete separation of the irrigation and aspiration systems andfunctions. As seen, both the irrigant and aspirant flows may bemaintained in separation from each other, providing a device where crosscontamination may be avoided. As previously described, the irrigationand/or aspiration systems and functions may have an interface region 13between the body 4 and the head 14. The interface region may directly orindirectly connect the pump 11 to the irrigation reservoir 30 and/or thevacuum pressure 49 to the aspiration reservoir 40, for example. Theinterface region 13 may be adapted to provide complete or partialseparation of the irrigation and aspiration systems and functions.

In some embodiments, irrigant 32 may be expelled from the irrigantreservoir 30 with mechanical pressure 180 applied either directly orindirectly to the irrigant reservoir 30 via control 10 and pump 11 (seeFIG. 35A). In other embodiments, irrigant 32 may be expelled from theirrigant reservoir 30 with mechanical pressure 180 applied to theirrigant reservoir 30 with a squeeze by the user (see FIG. 35B). A pump11 may or may not be included. The irrigant 32 flows out the irrigantreservoir 30, through the irrigation channel 36, and out the irrigationport 34. Either concurrently, or before, or after, or any combination,the pump 8 may be energized (e.g., via control 10 and motor 9) toproduce aspiration vacuum pressure 49 to draw air and aspirant 42 fromthe treatment region into the aspirant reservoir 40. The resultingvacuum 49 can draw aspirant flow 120, as shown by arrows, through theaspiration port 44 and into the aspirant reservoir 40. Barrier 24 mayprevent contaminated aspiration material 42 i.e., fluids, from enteringthe body 4.

FIG. 35A illustrates that the device 2 can have a first pump 8 and asecond pump 11. The first pump 8 and/or second pump 11 can be manual orautomatic (e.g., driven by an electric motor). For example the firstpump 8 can be automatic and the second pump 11 can be manual, as shown.The first pump 8 can provide aspirant suction pressure to the aspirantintake hose 172. The outgoing pressure from the first pump 8 can beexhausted through the exhaust hose 166 and/or exhaust port 168.

The second pump 11 can pressurize the irrigant 32 in the irrigationreservoir 30 and/or irrigation channel 36. The second pump 11 can bepumped to produce a force 180, as shown by arrow, for example by hand(e.g., with a thumb on a button). The second pump 11 can be actuated bya thumb 77 on a button 112 on the body 4 of the device 2. The irrigant32 can be delivered from the irrigation port 34 in a non-atomized streamor spray, or the irrigant 32 can be atomized upon passing through orexiting the flexible tip 18.

The button 112 can be in a position configured to produce aspiration andno irrigation. The button 112 can be in a position configured to produceirrigation and no aspiration. The button 112 can be in a positionconfigured to produce aspiration and irrigation. All or part of theexhaust pressure from the pump 8 can flow out of the device 2 as exhaustflow 170, as shown by arrows.

Separation of irrigation and aspiration functions allows for the device2 to be configured to prevent the irrigant 32 from the irrigantreservoir 30 from flowing solely from the application of vacuum pressure49 in the head 14, and more specifically in the aspirant channel 46 andaspirant reservoir 40.

V. Additional Embodiments A. Bulb Designs

FIG. 36 illustrates that the aspiration reservoir 256 can be a resilientcontainer, such as an elastomeric bulb 314. The aspiration reservoir 256can have an exhaust conduit 340. The exhaust conduit 340 can be in fluidcommunication with the aspiration reservoir 256. The exhaust conduit 340can have an exhaust valve 342 and an exhaust port 344. The exhaust valve342 can be a check valve configured to flow away from the aspirationreservoir 256.

The nozzle 259 can be integral with or removably attached to theaspiration reservoir 256. The aspiration port 260 nozzle 259 or theaspiration reservoir 256 can have an aspiration valve 346. Theaspiration valve 347 can be a check valve, for example, such as anumbrella check valve 347.

The irrigation component 320 can have an irrigation trigger 348. Theirrigation trigger 348 can be operated by a single digit. When theirrigation trigger 348 is pulled or squeezed, the irrigation component320 can dispense irrigant 257.

When the aspiration reservoir 256 is squeezed, the aspiration valve 347can close and the exhaust valve 342 can open. The aspirant 258 in theaspiration reservoir 256 can be forced out the exhaust conduit 340 andthe exhaust port 344. The exhaust valve 342 can be a duckbill valve.When the previously-squeezed aspiration reservoir 256 is relaxed, theexhaust valve 342 can close and the aspiration valve 347 can open.Suction can then result at the aspiration port 260 and aspirant 258 canbe drawn into the aspiration reservoir 256.

FIG. 37 illustrates that the aspiration valve 347 can be a duckbillvalve (the irrigation component 320 is not shown). The aspirationcomponent 322 and/or the device can have a base 350. The base 350 can beconfigured to enable the device 2 to stand on a flat surface (e.g., atable), for example, keeping the aspiration 260 and other ports off theflat surface.

FIG. 38 illustrates that the aspiration reservoir 256 can be in aresilient vacuum bulb 364. The vacuum bulb 364 can be elastomeric. Theaspiration reservoir 256 can be in fluid communication with the irrigantreservoir 254, for example, via an irrigation-aspiration port 366. Theirrigation-aspiration port 366 is configured to be away from theaspirant fluid level in the aspirant reservoir 256.

An irrigation-aspiration valve 368 can be in fluid communication withthe aspiration reservoir 256 and the irrigant reservoir 254. Theirrigation-aspiration valve 368 can be a check valve. Theirrigation-aspiration valve 368 can be a valve permitting flow only fromthe aspiration reservoir 256 to the irrigant reservoir 254 andpreventing flow from the irrigant reservoir 254 to the aspirationreservoir 256.

The aspiration valve 346 can be a one-way check valve permitting flowinto the aspiration reservoir 56.

The irrigant reservoir 254 can be in an irrigant container 370. Theirrigant container 370 can be rigid, for example a plastic bottle. Theirrigant container 370 can be integral with or removably attachable tothe remainder of the device at an attachable reservoir joint 372. Theatomization fluid reservoir 374 can be the top of the irrigant reservoir254, above the level of the irrigant 257.

The base 350 can extend from the reservoir container. The base 350 canbe wider than the widest portion of the remainder of the device 2.

Squeezing the vacuum bulb 364 can atomize and eject irrigant 257 fromthe atomization port 246. For example, when the vacuum bulb 364 issqueezed, the irrigation-aspiration valve 363 can open and the irrigantreservoir 254 can be pressurized via the irrigation-aspiration port 366.The increased pressure in the irrigant reservoir 254 can cause theirrigant 257 to flow through the irrigation channel 224. The increasedpressure in the irrigant reservoir 254 can also force gas in theirrigant reservoir 254 (e.g., above the irrigant 257) through theatomization channel 220.

Relaxing the previously squeezed irrigation-aspiration valve 368 cansuction aspirant 258 into the aspiration reservoir 256. For example, theirrigation-aspiration valve 368 can close. The negative pressure in theaspiration reservoir 256 can draw in aspirant 258 by opening theaspiration seal 294 in the aspiration port 260.

FIG. 39 illustrates that one or more covers 375 can be configured to fitover the aspiration 260 and/or irrigation 248 and/or atomization ports246.

The device 2 can have a manually or automatically controllable dualexhaust valve 376. The dual exhaust valve 376 can be passive or active.The dual exhaust valve 376 can regulate excessive fluid pressure fromthe aspiration reservoir 256 and/or the irrigant reservoir 254 to anexhaust conduit 340. The excessive fluid pressure can exit the exhaustconduit 340 as an exhaust flow, shown by arrow.

An irrigation valve 378 can regulate flow from the irrigant reservoir254 to the irrigation port 248. The irrigation valve 378 can beconfigured to prevent the irrigant 257 from exiting the irrigation port248 at an excessive pressure. The velocity of the irrigant 257 flowstream can be prevented from exiting the device 2 at an excessivevelocity.

FIGS. 40 and 41 illustrate that the aspirant reservoir 256 can be in aninner irrigant reservoir wall 380. The irrigant reservoir 254 can bebetween an inner irrigant reservoir wall 380 and an outer irrigantreservoir wall 382. The inner irrigant reservoir wall 380 and the outerirrigant reservoir wall 382 can be rigid, resilient or deformable.

The device 2 can have an atomization intake port 384 on the outsidesurface of the device 2. The atomization intake port 384 can be in fluidcommunication with the atomization fluid reservoir 374. The atomizationintake port 384 can have a check valve configured to allow one-way flowfrom the atomization intake port 384 to the atomization fluid reservoir374.

The atomization valve 386 can regulate flow between the irrigantreservoir 254 to the atomization channel 220. The atomization channel220 can have a venturi 385 configuration adjacent to the irrigation port248. The venturi 385 can atomize the irrigant 257 and/or increase thespeed of the atomization gas.

The irrigant valve 378 can regulate flow between the irrigant reservoir254 and the irrigant channel 224. The irrigant valve 378 can be a checkvalve. The irrigant valve 378 can prevent flow from the irrigant channel224 to the irrigant reservoir 254. The irrigant valve 378 can permitsubstantially free flow from the irrigant reservoir 254 to the irrigantchannel 224. The irrigant valve 378 can restrict the flow from theirrigant reservoir 254 to the irrigant channel 224 except under highpressure differentials, for example a pressure differential greater thanabout 25 mmHg (0.5 psi), more narrowly a pressure differential greaterthan about 100 mmHg (2 psi), more narrowly a pressure differentialgreater than about 260 mmHg (5 psi), more narrowly a pressuredifferential greater than about a pressure differential greater thanabout 760 mmHg (14.7 psi), for example for a pressure differentialgreater than about 1600 mmHg (30 psi).

An irrigant intake port 388 can be in fluid communication with theirrigant reservoir 254. The irrigant intake port 388 can have a checkvalve configured to allow one-way flow from the irrigant intake port 388to the irrigant reservoir 254. The irrigant reservoir 254 can be filledby introducing irrigant 257 through the irrigant intake port 388.

The aspiration channel 226 can have a valve transition zone 390. Thevalve transition zone 390 can be configured as a smooth transition fromthe inner wall of the aspiration channel 226 to the inner wall of theaspirant valve 346.

An exhaust valve 342 can regulate flow between the aspirant reservoir256 and the exhaust port 344. The exhaust port 344 can be covered anduncovered by the user (e.g., by a digit 76, such as the thumb 77) duringuse. The exhaust can flow from the aspirant reservoir 256 and out theexhaust port 344, as shown by arrow.

The device 2 shown in FIGS. 40 and 41 can be squeezed to deliver theirrigant 257. Releasing the device 2 from a squeezed configuration canaspirate.

FIG. 41 shows that the irrigant 257 and atomization fluid can be mixed amixing valve 392. The mixing valve 392 can be upstream from theatomization port 246.

FIG. 42 illustrates that the device 2, such as the variation shown inFIG. 36, can be actuated to irrigate by rotating 508 a trigger 245 on ahinge, for example with one or more digits 76 (e.g., the forefingerand/or middle finger). The aspirant reservoir 256 can be completely orpartially emptied by compressing 241, as shown by arrows, the aspirantreservoir 256, for example with the thumb 77, ring finger, pinky andpalm 74. The aspirant 258 can be drawn into the aspiration port 260 byreleasing the compressed aspirant reservoir 256.

Variations of the device 2, such as those shown in FIGS. 36 through 42,can be actuated by squeezing (e.g., for irrigation) and releasing (e.g.,for aspiration) all or part of a resilient portion of the device 2, suchas a bulb 314.

B. Remote Head

FIG. 43 illustrates that the device 2 can have a head 14 that can becoupled to a body 4 with a lead 200, and/or the head 14 can be coupledto a separate vacuum source, such as wall vacuum and/or a portablevacuum pump, for example. This embodiment may incorporate any and allthe features disclosed in the description of the device 2, except thisembodiment comprises the additional feature of providing a remote head14.

The lead 200 can carry the irrigant channel 36, and/or aspirant channel46, and/or coupling to control 10, and/or coupling to a wall vacuumsource and/or coupling to a portable vacuum pump, or combinationsthereof. The lead 200 can be flexible. The lead 200 can be retractableinto the body 4, for example with a spring-loaded retraction mechanism.The lead 200 can be coiled.

The head 14 can have a removably attached aspirant reservoir 40 and/orirrigant reservoir 30. The head 14 may include a handle 202 to aid inuse and control of the head 14 and/or body 4. The head 14 and/or thehandle 202 may include a pump 204 to produce the irrigant pressurenecessary to expel irrigant. The head may be squeezed to produce theirrigant pressure necessary to expel irrigant.

The body 4 can take on any convenient shape, and may have a flat base206 for support. The body 4 can be attached to a surface such as a flatsurface (e.g., floor, table, crib), for example with screws, nails,brads, bolts or combinations thereof. The body 4 can be weighted withballast and/or have a clamp (e.g., to stabilize).

C. Dual Tip Nozzle

FIG. 44 illustrates that the device 2 can have a head 14 that includesmore than one nozzle, i.e., flexible tips, as two flexible tips 194, 195are shown. Some embodiments may incorporate any and all the featuresdisclosed in the description of the device 2, except some embodimentsinclude the additional feature of dual flexible tips 194, 195.

Simultaneous or intermittent irrigating and aspirating the targetregion, e.g., the nasal and/or sinus cavities from one nostril to theother, may be advantageous. Dual tips 194, 195 allow irrigant 32 to beexpelled into one nostril while simultaneously or intermittently beingaspirated out the other nostril (see FIG. 45).

In some embodiments, the irrigation fluid 32 may be provided as a finemist to a high volume stream of irrigant 32. Irrigant 32 may be expelledcontinuously or in a pulsed fashion. Aspiration may be continuous orintermittent. The process of irrigation and aspiration may beautomatically or manually timed for a cleaning cycle (i.e., irrigationand aspiration).

D. Alternative Pressure

FIG. 46 illustrates that some embodiments of the device 2 can have apump configuration comprising a trigger or handle 208 adapted togenerate a sufficient pressure for the aspiration and/or irrigationfunctions. The handle 208 may be used to generate either or bothpositive and negative pressures. The pressure may be stored in acontainer or canister 210 as it is generated, and then released via thecontrols 10, for example, or the pressure may be generated as needed.The handle 208 may be coupled to a pump, such as pump 8 and/or 11, aspreviously described, and/or the handle may be coupled to a bellows orbaffle combined with a one way valve, or alternatively a flywheel pumpdesign to generate a relatively constant pressure, e.g., vacuum.

FIG. 47 illustrates that some embodiments of the device 2 can have apump configuration comprising a canister 210 or other supply ofcompressed gas (e.g., air, carbon dioxide, oxygen, and/or nitrogen).Embodiments of the device 2 can be configured to controllably generate asupply of compressed gas, and then controllably release the compressedgas to produce a venturi effect, thereby creating sufficient pressurefor the aspiration and/or irrigation functions.

In some embodiments, the compressed gas is manually generated by theuser. For example, handle 208 may be used to generate a gas underpressure for immediate use, or for storage in a canister 210. Aspreviously described, a resilient container, such as an elastomeric bulb314 may be used to create and/or store a compressed gas.

In some embodiments, the compressed gas may be removable andreplaceable, and/or automatically generated. For example, canister 210may be a removable and replaceable snap-in canister containing a supplyof compressed gas, and when the supply of compressed gas is exhausted,the canister 210 is replaced with a new canister. The recharger base 62may also comprise a high pressure pump that recharges canister 210 witha fresh supply of compressed gas.

FIGS. 48A through 49B illustrate alternative embodiments of the device 2can have a pump configuration comprising a baffle or bellows 214 adaptedto generate a sufficient pressure for the aspiration and/or irrigationfunctions. The bellows 214 may be used to generate either or bothpositive and negative pressures. As previously described, the pressuremay be stored in a container or canister 210 as it is generated, andthen released via the controls 10, for example, or the pressure may begenerated as needed. The bellows 214 may be coupled to a pump, such aspump 8 and/or 11, as previously described, and/or the bellows 214 may becombined with a one way valve to generate a relatively constantpressure, e.g., vacuum. FIGS. 48A and 48B show an embodiment where thebellows are located on the device 2 where the bellows are easilycontrolled with the user's hand or digits. FIGS. 49A and 49B show anembodiment where the bellows are located on the device 2 near or at itsbase.

VI. Instructions for Use

The instructions for use 58 can direct the use of an irrigation andaspiration device 2, including a device 2 adapted to be hand-held andcontrollable with one or more digits (i.e., fingers 76 or thumb 77). Theinstructions for use may include instructions for irrigation and/oraspiration in a nasal cavity, for example. The instructions for use mayalso include instructions for using the head 14 as a diagnostics device,such as for testing the contents of the head 14 and/or aspirationreservoir 40, for example, as will be described below.

FIGS. 26 through 29 show representative embodiments of the steps thatrepresentative instructions for use 58 can incorporate or direct.

A. Irrigate and Aspirate

The instructions may include a series of steps that can be followed tocarry out the irrigation and aspiration procedures. It is to beappreciated that the device 2 may be used for only irrigation, or onlyaspiration, or irrigation, then aspiration, or aspiration, thenirrigation, or irrigation and aspiration simultaneously. Theinstructions may be provided for the benefit of the person controllingthe device 2, which may be a user, or a patient, or the user may be thepatient. These steps may include, but are not limited to:

(i) confirm the irrigation and aspiration device 2 contains a desiredsupply of irrigation fluid 32;

(ii) confirm the device 2 is operational, which may include testing theirrigation function and the aspiration function by pressing the button112 to confirm the flow of irrigation fluid 32 and that aspirationsuction is available;

(iii) position the flexible tip 18 at the vestibule of the nostril, andapply an inward force to gently seal the bulbous tip 82 against thenostril; a variety of positions may be used, for example, with use on ababy, the user may sit on a bed with the baby between the users legs,and holding the baby's head down with one hand, use the device 2 withthe other hand; or, swaddle the baby in a blanket, and place the baby ona changing table, hold the head with one hand and use the device 2 withthe other; or, cradle the baby with the head in the user's armpit andplace an arm over the baby's arms and use the device with the other;

(iv) using the controls 10, apply a downward force 114, e.g., with thethumb 77, on a first portion of the button 112 to expel irrigation fluidfrom the irrigation reservoir 30, through the tip 18, and into the nasaland/or sinus cavities;

(v) again using the controls 10, apply a downward force 116, e.g., withthe thumb 77, on a second portion of the button 112 to produce anaspiration pressure to draw irrigation fluid 32 and mucus (i.e.,aspiration fluid 42) from the nasal and/or sinus cavities through thetip 18 and into the aspiration reservoir 40;

(vi) steps (iv) and (v) may be repeated as desired, while confirming theirrigation reservoir 30 contains a supply of irrigation fluid 32, andthe aspiration reservoir 40 contains space for additional aspirationfluid 42;

(vii) if necessary, the irrigation reservoir 30 may be refilled withirrigation fluid 32 (or the irrigation reservoir 30 may be removed andreplaced with a full irrigation reservoir 30, and the aspirationreservoir 40 may be emptied (or the aspiration reservoir 40 may beremoved and replaced with an empty aspiration reservoir 40);

(viii) optionally, steps (iv) and (v) may be followed simultaneously tosimultaneously irrigate and aspirate.

(ix) after use, the irrigation reservoir 30 and/or the aspirationreservoir 40 may be removed, and/or replaced and/or cleaned for reuse.

The instructions may include a series of steps that can be followed tocarry out the irrigation and aspiration procedures for displacement ofsinus content and complete cleansing of the sinus cavity. These stepsmay use the venture effect of rapidly moving irrigation fluid as it goesby the sinus ostea and thereby displace the sinus content (i.e., mucus)with irrigation fluid, approximating the Proetz displacement procedure.

These steps may include the steps as described above, and may alsoinclude, but are not limited to:

(i) confirm the irrigation and aspiration device 2 contains a desiredsupply of irrigation fluid 32;

(ii) confirm the device 2 is operational, which may include testing theirrigation function and the aspiration function by pressing the button112 to confirm the flow of irrigation fluid 32 and that aspirationsuction is available;

(iii) have the patient laying down with the head in the snuff position.

(iv) position the flexible tip 18 at the vestibule of the nostril, andapply an inward force to gently seal the bulbous tip 82 against thenostril;

(v) using the controls 10, apply a downward force 114, e.g., with thethumb 77, on a first portion of the button 112 to expel irrigation fluidfrom the irrigation reservoir 30, through the tip 18, and into one sideof the nose to fill the nasal cavity;

(vi) simultaneously or just afterwards, again using the controls 10,apply a downward force 116, e.g., with the thumb 77, on a second portionof the button 112 to produce an aspiration pressure to apply suction tothe other side of the nose while intermittently occluding the salineirrigated nostril, and apply suction for approximately three to fiveseconds at a time until satisfied of evacuation. It may be helpful tohave the patient say “K-K-K-K” while applying the suction as it closesthe vallecula and allows a more closed circuit.

B. Diagnose Contaminated Fluids

The instructions may include a series of steps that can be followed tocarry out a contaminated fluids diagnostics procedure. It is to beappreciated that the diagnostics procedure may be performedautomatically by the diagnostic means 22, as described below, or theaspirant reservoir 40 and/or head 14 may be removed and sent to a labfor further testing. These steps may include, but are not limited to:

(i) use of the device 2 (see instructions above) for at least aspirationto collect a supply of aspiration fluid 42 within the aspirationreservoir 40;

(ii) present the aspiration fluid 42 directly to the diagnostic means22, or by first drawing the fluid 42 into a sample chamber 92, which maybe accomplished by shaking the head 14 (or the device 2) so as to drawthe fluid sample 42 into the chamber 92, or by capping the flexible tip18 with the cap 20, or finger 76, and actuating the aspiration functionagain so as to cause an occluded suction, which draws the aspirationfluid 42 into the chamber 92;

(iii) once a predetermined amount of fluid 42 is within the chamber 92,which may be predetermined by the size of the chamber, it may beavailable to an analysis system 90 as part of the diagnostic means 22for testing, or the fluid 42 may be combined with a reagent from thechamber 92 or other chamber to form an aliquot to then be delivered tothe analysis system 90;

(iv) the sample or aliquot may then be presented to the analysis system90 by taking an action such as manually popping a blister 94, or thepush of a button, or movement of a switch, on the side of the head 14 toallow entry of the sample or aliquot into and/or onto the analysissystem 90;

(v) the diagnostic means 22 may then display and/or present a result orresults of the test(s), which may be displayed as a change of color ofan indicator on or in the diagnostic means 22 and/or head 14, or a teststrip may be removed from the diagnostic means, or visible within thehead 14 and/or aspiration reservoir 40, for example;

(vi) the head 14 and/or diagnostic means 22 may then be disposed of, orthe head 14 and/or diagnostic means 22 may be sent to a lab for anyadditional actions.

The foregoing is considered as illustrative only of the principles ofthe invention. Furthermore, since numerous modifications and changeswill readily occur to those skilled in the art, it is not desired tolimit the invention to the exact construction and operation shown anddescribed. While the preferred embodiment has been described, thedetails may be changed without departing from the invention, which isdefined by the claims.

1. A hand-held test device comprising: a hand-held housing, the housingincluding a head and a base, the head and base being adapted to bereleasably coupled to each other at an interface region, an aspirantreservoir within the housing, the aspirant reservoir adapted to containaspirated fluid, pumping means within the housing adapted to draw fluidinto the aspirant reservoir, and a diagnostic means within the housingfor testing the aspirated fluid, the diagnostic means adapted to providean indication of the results of testing the aspirated fluid.
 2. Thedevice according to claim 1: further including a barrier means withinthe housing adapted to retain liquid in the aspirant reservoir and allowgas to pass out of the aspirant reservoir.
 3. The device according toclaim 1: wherein the diagnostic means comprises at least one of a teststrip, an electrical chip, a chemical, and a genetic plate.
 4. Thedevice according to claim 1: wherein the diagnostic means is containedwithin the head.
 5. The device according to claim 1: wherein thediagnostic means is adapted to provide test results.
 6. The deviceaccording to claim 1: wherein the diagnostic means is contained withinthe aspirant reservoir.
 7. The device according to claim 6: wherein thediagnostic means includes a sub-chamber within the aspirant reservoir,the sub-chamber adapted to deliver a predetermined volume of aspiratedfluid to the diagnostic means.
 8. The device according to claim 7:wherein the sub-chamber includes a port in fluid communication with theaspirant reservoir that allows negative pressure of the device tocontrol sub-chamber filling.
 9. The device according to claim 7: furtherincluding a flexible portion adapted to be pressed to facilitate atleast one of sub-chamber filling and evacuation of the aspirated fluidto the diagnostic means.
 10. The device according to claim 7: furtherincluding a flexible portion adapted to induce the addition of adiagnostic test reagent/primer into the sub-chamber to then be deliveredto the diagnostic means.
 11. The device according to claim 1: furtherincluding a power source within the housing.
 12. The device according toclaim 1: wherein the diagnostic means accommodates microbiologic testsincluding influenza A and B, avian flu, RSV (respiratory syncytialvirus), adenovirus, Legionella, CNV, EBV, Group A beta hemolyticstreptococcus, S. pneumoniae, N. meningitides, mycoplasma, Staphloccusaureus, Malaria, HIV, rhinovirus, coccsackie virus, smallpox, anthrax,botulinum toxin, ricin, ebola, rabies, brucellosis, (plague) yersiniapestis, coxeilla burnetti (Q fever), T2 mycotoxins, francisellatularensis (tularemia), viral equine encephalitis, viral hemorrhagicfever, and burkholdria mallei (glanders).
 13. The device according toclaim 1: wherein the diagnostic means accommodates toxicologic and/orchemical tests including amphetamines, cocaine, opiates, phencyclidine,tetrahydrocannabinol, acetaminophen, barbiturates, benzodiazepines,methadone, propoxyhenone, tricyclic antidepressants, calcium channelblockers, ethyl alcohol, ethylene glycol, ketones, glucose,hypoglaecemics, cytokines, interleukins, insulin, Hemoglobin A1C,electrolytes, human choreonic gonadotropin (pregnancy test),thyroid-stimulating hormone (TSH), T3 blood test, T4 blood test,c-reactive protein (CRP), and erythrocyte sedimentation rate (ESR). 14.The device according to claim 1: wherein the diagnostic meansaccommodates real time polymerase chain reaction tests and/orimmunoassays for viruses, bacteria, and cancers.
 15. The deviceaccording to claim 1: further including pumping means within the housingadapted to expel irrigation fluid from an irrigant reservoir, theirrigant reservoir adapted to contain irrigation fluid.
 16. The deviceaccording to claim 1: further including at least one nozzle extendingfrom the housing, the nozzle including an irrigant lumen and an aspirantlumen, the irrigant lumen adapted to provide fluid communication betweenthe irrigant reservoir and an irrigant port, the aspirant lumen adaptedto provide fluid communication between the aspirant reservoir and anaspirant port.
 17. The device according to claim 1: wherein theinterface region comprising at least one non-fluid flow component and atleast one gas flow component, the interface region coupling the head tothe base.
 18. The device according to claim 1: wherein the interfaceregion comprises a seal between the head and the base, the seal adaptedto allow a force exerted on the base to be transferred to the head, andthe seal adapted to allow an aspiration pressure from the base to draw agas out of the aspiration reservoir and into the base.
 19. A test devicecomprising: a housing, an aspirant reservoir within the housing, theaspirant reservoir adapted to contain aspirated fluid, and a diagnosticmeans for testing the aspirated fluid, the diagnostic means adapted toprovide an indication of the results of testing the aspirated fluid. 20.The device according to claim 19: further including coupling means tocouple the device to a source of vacuum.
 21. The device according toclaim 19: further including pumping means for drawing fluid into theaspirant reservoir.
 22. The device according to claim 21: wherein thepumping means draws the aspirated fluid into or onto the diagnosticmeans.
 23. The device according to claim 19: wherein the diagnosticmeans is adapted to provide test results.
 24. The device according toclaim 23: wherein the test results comprise an indication on or in thehousing.
 25. The device according to claim 19: wherein the diagnosticmeans includes a sub-chamber within the aspirant reservoir, thesub-chamber adapted to deliver a predetermined volume of aspirated fluidto the diagnostic means.
 26. The device according to claim 25: whereinthe sub-chamber includes a port in fluid communication with the aspirantreservoir that allows negative pressure of the device to controlsub-chamber filling.
 27. The device according to claim 25: furtherincluding a flexible portion adapted to be pressed to facilitate atleast one of sub-chamber filling and evacuation of the aspirated fluidto the diagnostic means.
 28. The device according to claim 25: furtherincluding a flexible portion adapted to induce the addition of adiagnostic test reagent/primer into the sub-chamber to then be deliveredto the diagnostic means.
 29. The device according to claim 19: whereinthe diagnostic means accommodates microbiologic tests includinginfluenza A and B, avian flu, RSV (respiratory syncytial virus),adenovirus, Legionella, CNV, EBV, Group A beta hemolytic streptococcus,S. pneumoniae, N. meningitides, mycoplasma, Staphloccus aureus, Malaria,HIV, rhinovirus, coccsackie virus, smallpox, anthrax, botulinum toxin,ricin, ebola, rabies, brucellosis, (plague) yersinia pestis, coxeillaburnetti (Q fever), T2 mycotoxins, francisella tularensis (tularemia),viral equine encephalitis, viral hemorrhagic fever, and burkholdriamallei (glanders).
 30. The device according to claim 19: wherein thediagnostic means accommodates toxicologic and/or chemical testsincluding amphetamines, cocaine, opiates, phencyclidine,tetrahydrocannabinol, acetaminophen, barbiturates, benzodiazepines,methadone, propoxyhenone, tricyclic antidepressants, calcium channelblockers, ethyl alcohol, ethylene glycol, ketones, glucose,hypoglaecemics, cytokines, interleukins, insulin, Hemoglobin A1C,electrolytes, human choreonic gonadotropin (pregnancy test),thyroid-stimulating hormone (TSH), T3 blood test, T4 blood test,c-reactive protein (CRP), and erythrocyte sedimentation rate (ESR). 31.The device according to claim 19: wherein the diagnostic meansaccomodating real time polymerase chain reaction tests and/orimmunoassays for viruses, bacteria, and cancers.
 32. A method ofdiagnosing an aspirated substance, the method comprising: providing ahand-held test device, the test device comprising a hand-held housing,the housing including a head and a base, the head and base adapted to bereleasably coupled to each other at an interface region, an aspirantreservoir within the housing, the aspirant reservoir adapted to containaspirated fluid, the aspirant reservoir in fluid communication with anozzle in the head, pumping means within the housing adapted to drawfluid into the aspirant reservoir, control means adapted to operate thepumping means, and a diagnostic means within the housing for testing theaspirated fluid, the diagnostic means adapted to provide an indicationof the results of testing the aspirated fluid, positioning the nozzle onor in an orifice, using the control means to activate the pumping meansto draw fluid from the orifice, through the nozzle, and into theaspirant reservoir, using the hand-held test device to provide a sampleof the aspirated fluid to the diagnostic means, testing the aspiratedfluid while the fluid remains in the housing, and providing anindication of the results of the testing.
 33. The method according toclaim 32: further including an irrigant reservoir within the housing,the irrigant reservoir adapted to contain irrigation fluid, and usingthe control means to expel irrigation fluid from the irrigationreservoir, through the nozzle, and into the orifice.
 34. The methodaccording to claim 32 wherein the interface region comprising at leastone non-fluid flow component and at least one gas flow component, theinterface region coupling the head to the base.
 35. A kit of devices toprovide an irrigation and aspiration system, the kit comprising: a head,an aspirant reservoir within the head, the aspirant reservoir adapted tocontain aspirated fluid, at least one nozzle extending from the head,the nozzle including an aspirant lumen, the aspirant lumen adapted toprovide fluid communication between the aspirant reservoir and anaspirant port, and a diagnostic means within the head for testing theaspirated fluid, a body, the body adapted to releasibly couple to thehead, the body including pumping means adapted to draw fluid into theaspirant port and through the aspirant lumen and into the aspirantreservoir, and control means to operate the pumping means adapted todraw aspirated fluid, and instructions for use describing the operationand use of the irrigation and aspiration system, the instructionscomprising the operations of: positioning the nozzle on or in anorifice, using the control means to activate the pumping means to drawfluid from the orifice, through the nozzle, and into the aspirantreservoir, using the hand-held test device to provide a sample of theaspirated fluid to the diagnostic means, testing the aspirated fluidwhile the fluid remains in the housing, and providing an indication ofthe results of the testing.